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FDA recall, , Moderate risk

Boston Scientific Direxion Torqueable Microcatheters

The Direxion Torqueable Microcatheter is defective due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

Summary by Recall Canary from the FDA notice

What happened

Boston Scientific Cork, Ltd. recalled the Direxion Torqueable Microcatheter because the product is defective due to insufficient UV curing of the hydrophilic coating on the outer surface of the distal segment and raised ridges on nitinol sleeves due to laser cutting misalignment. The recall began September 16, 2026, and was added to the FDA's Enforcement Report on October 22, 2026. Distribution was worldwide, including US Nationwide and Puerto Rico, and other countries.

More device defect recalls

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

41 products

Match the UDI-DI and lot code listed under your product.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Direxion Torqueable Microcatheter, NGMC/Transend/027/BERN/1RO/130; Material Number: M001195940

    UDI-DI
    • 08714729839842
    Lot code
    • 38061297
    • 38092418
    • 38149838
    • 38181982
    • 38224592
    • 38240234
    • 38240236
    • 38273745
    • 38649863
    • 38810593
    • 39143039
    • 39189852
    • 40466138
    • 40466139
    • 40466464
    • 40470781
    • 40476389
    • 40478986
    • 40497669
    • 40502265
    • 40507286
    • 40512989
    • 40525717

  2. Direxion Torqueable Microcatheter, NGMC/Fathom/021/STRAIGHT/1RO/130; Material Number: M001195610

    UDI-DI
    • 08714729839606
    Lot code
    • 37775581
    • 37914469
    • 37914471
    • 38112478
    • 38149824
    • 38149825
    • 38181969
    • 38290725
    • 38342768
    • 38342769
    • 38647607
    • 38647608
    • 38647615
    • 38647616
    • 38649502
    • 38687333
    • 38687334
    • 38708446
    • 39029659
    • 40466126
    • 40466127
    • 40466473
    • 40476395
    • 40485647
    • 40485732
    • 40501047
    • 40504656
    • 40504657
    • 40508315
    • 40512996
    • 40512997
    • 40519832
    • 40519833

  3. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105; Material Number: M001195200

    UDI-DI
    • 08714729839316
    Lot code
    • 37942457
    • 37999053
    • 38224527
    • 38304916
    • 38415911
    • 38687159
    • 38707977
    • 38916519
    • 39029416
    • 39029419
    • 39029640
    • 39092278
    • 40476286
    • 40479386
    • 40523958
    • 40525677

  4. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155; Material Number: M001195480

    UDI-DI
    • 08714729839552
    Lot code
    • 38649876
    • 38668791
    • 39074172
    • 39074173
    • 40482627
    • 40482628

  5. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155; Material Number: M001195330

    UDI-DI
    • 08714729839446
    Lot code
    • 37957742
    • 38361997
    • 38361998
    • 38439368
    • 38527323
    • 38527324
    • 38527326
    • 38876179
    • 38916511
    • 39029983
    • 39029986
    • 39092697

  6. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340

    UDI-DI
    • 08714729839453
    Lot code
    • 37818442
    • 38181218
    • 38181219
    • 38224580
    • 38240231
    • 38350326
    • 38361999
    • 38460468
    • 38484291
    • 38503334
    • 38530454
    • 38530455
    • 38629574
    • 38650064
    • 38745484
    • 38769974
    • 38769975
    • 38904812
    • 38904813
    • 38937271
    • 38937272
    • 38990884
    • 39092686
    • 39092687
    • 40476309
    • 40476444
    • 40482608
    • 40507288
    • 40510453
    • 40525536
    • 40525537

  7. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300

    UDI-DI
    • 08714729839415
    Lot code
    • 37818213
    • 37818214
    • 37818215
    • 37818216
    • 37881115
    • 37886786
    • 37886787
    • 37886788
    • 37914463
    • 37914464
    • 37914465
    • 37943140
    • 37956679
    • 37957740
    • 37977611
    • 38002444
    • 38002445
    • 38085044
    • 38089225
    • 38092404
    • 38092405
    • 38092406
    • 38112470
    • 38112471
    • 38112472
    • 38149820
    • 38181217
    • 38191752
    • 38220950
    • 38330637
    • 38330638
    • 38415914
    • 38415915
    • 38444073
    • 38444074
    • 38484290
    • 38527320
    • 38527321
    • 38560452
    • 38573062
    • 38573063
    • 38585014
    • 38596980
    • 38596981
    • 38629571
    • 38629572
    • 38769972
    • 38769973
    • 38827700
    • 38827701
    • 38827702
    • 38827703
    • 38827704
    • 38827705
    • 38904809
    • 38904810
    • 38916514
    • 38916515
    • 38937265
    • 38990849
    • 38990852
    • 38990856
    • 38990857
    • 39029815
    • 39143228
    • 39143230
    • 40466130
    • 40466131
    • 40466631
    • 40471499
    • 40471940
    • 40476290
    • 40476291
    • 40476292
    • 40479473
    • 40479474
    • 40479716
    • 40479717
    • 40492475
    • 40493319
    • 40493333
    • 40493440
    • 40497672
    • 40499680
    • 40499681
    • 40505968
    • 40505969
    • 40512591
    • 40512592
    • 40512593
    • 40513026
    • 40513027
    • 40521923
    • 40521924
    • 40525798
    • 40525799
    • 40525860
    • 40531461
    • 40531462
    • 40533302
    • 40535971
    • 40535972

  8. Direxion Torqueable Microcatheter, NGMC/Fathom/027/BERN/1RO/130; Material Number: M001195740

    UDI-DI
    • 08714729839712
    Lot code
    • 38092416
    • 38112643
    • 38149830
    • 38181974
    • 38224588
    • 38224589
    • 38259488
    • 38273747
    • 38273748
    • 38290697
    • 38330742
    • 38399250
    • 38416365
    • 38445016
    • 38484295
    • 38593059
    • 38595656
    • 38649843
    • 38649864
    • 38745197
    • 38810587
    • 38810592
    • 38876171
    • 38876172
    • 38904806
    • 38937263
    • 38990883
    • 39092270
    • 39143220
    • 39189853
    • 39189855
    • 40485616
    • 40485617
    • 40492473
    • 40493384
    • 40497670
    • 40497857
    • 40499760
    • 40499761
    • 40502300
    • 40502325
    • 40507454
    • 40518477
    • 40518478
    • 40525595
    • 40525718
    • 40525719
    • 40536127

  9. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155; Material Number: M001195250

    UDI-DI
    • 08714729839361
    Lot code
    • 37886785
    • 37981348
    • 38022667
    • 38022668
    • 38049175
    • 38149678
    • 38224535
    • 38259480
    • 38259481
    • 38323413
    • 38446235
    • 38506483
    • 38560459
    • 38560740
    • 38560741
    • 38595642
    • 38595643
    • 38644774
    • 38708452
    • 38745193
    • 38810251
    • 38904563
    • 38904564
    • 38937261
    • 38990880
    • 39027325
    • 39027326
    • 39092681
    • 39092682
    • 39140994
    • 39140995
    • 39141262
    • 39141263
    • 40482688
    • 40482689
    • 40502253
    • 40507285
    • 40512991
    • 40512992
    • 40525712
    • 40531379
    • 40537145

  10. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440

    UDI-DI
    • 08714729839514
    Lot code
    • 38181961
    • 38198832
    • 38224582
    • 38259483
    • 38324070
    • 38460469
    • 38560455
    • 38560456
    • 38595654
    • 38649857
    • 38745194
    • 38745195
    • 38810586
    • 38810591
    • 38904805
    • 39092267
    • 39092272
    • 39143222
    • 40470259
    • 40478976
    • 40478977
    • 40492318
    • 40497671
    • 40497858
    • 40502038
    • 40502039
Show all 41 products

  1. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105; Material Number: M001195430

    UDI-DI
    • 08714729839507
    Lot code
    • 38149822
    • 38210076
    • 38415917
    • 38595649
    • 38708406
    • 39141265

  2. Direxion Torqueable Microcatheter, NGMC/Fathom/021/STRAIGHT/1RO/155; Material Number: M001195620

    UDI-DI
    • 08714729839613
    Lot code
    • 37775591
    • 37886793
    • 37914472
    • 37914473
    • 37957744
    • 38112479
    • 38149826
    • 38167704
    • 38175797
    • 38444076
    • 38446234
    • 38530457
    • 38745190
    • 38990885
    • 39140998
    • 39140999
    • 40470358
    • 40499682
    • 40499683
    • 40502254
    • 40504732
    • 40504733
    • 40507436
    • 40524004
    • 40539147
    • 40539467

  3. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155; Material Number: M001195450

    UDI-DI
    • 08714729839521
    Lot code
    • 38224583
    • 38273637
    • 38649877
    • 38707975
    • 38745198
    • 40470668
    • 40470669
    • 40476288
    • 40476289
    • 40476304
    • 40476305
    • 40495080
    • 40504684
    • 40512595
    • 40516625
    • 40516626
    • 40523967
    • 40525596
    • 40531425

  4. Direxion Torqueable Microcatheter, NGMC/Fathom/027/STRAIGHT/1RO/130; Material Number: M001195710

    UDI-DI
    • 08714729839682
    Lot code
    • 38092414
    • 38149829
    • 38181972
    • 38259486
    • 38324071
    • 38416363
    • 38593058
    • 38595655
    • 38629567
    • 38649848
    • 38745196
    • 38810589
    • 38810590
    • 38937264
    • 39092268
    • 40465990
    • 40466018
    • 40466019
    • 40466137

  5. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130; Material Number: M001195270

    UDI-DI
    • 08714729839385
    Lot code
    • 37914462
    • 37956678
    • 38079823
    • 38079827
    • 38079828
    • 38181215
    • 38224537
    • 38290724
    • 38399239
    • 38399240
    • 38399241
    • 38446224
    • 38460466
    • 38479514
    • 38479518
    • 38506192
    • 38506193
    • 38527327
    • 38527328
    • 38560748
    • 38560749
    • 38560750
    • 38560751
    • 38629561
    • 38647619
    • 38649500
    • 38649513
    • 38769494
    • 38769500
    • 38827706
    • 38990346
    • 38990347
    • 39074447
    • 39191592
    • 40476394
    • 40482557
    • 40487835
    • 40487836
    • 40507432
    • 40513948
    • 40521921
    • 40521922
    • 40524021
    • 40524022
    • 40533341
    • 40535977
    • 40539682

  6. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130; Material Number: M001195500

    UDI-DI
    • 08714729839576
    Lot code
    • 38061298
    • 38061299
    • 38092411
    • 38092412
    • 38092413
    • 38112475
    • 38112476
    • 38112477
    • 38167702
    • 38167705
    • 38181964
    • 38181965
    • 38181966
    • 38181967
    • 38181968
    • 38416361
    • 38416362
    • 38595650
    • 38595651
    • 38595652
    • 38650001
    • 38650003
    • 38746409
    • 38746410
    • 38810247
    • 38810248
    • 38904814
    • 38904815
    • 38937266
    • 38937267
    • 38937268
    • 38937270
    • 38990858
    • 39027320
    • 39092275
    • 39092276
    • 39092277
    • 40466592
    • 40466593
    • 40471963
    • 40471964
    • 40478978
    • 40478979
    • 40502334
    • 40502335
    • 40504653
    • 40504654
    • 40513028
    • 40513029
    • 40513030
    • 40524000

  7. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155; Material Number: M001195420

    UDI-DI
    • 08714729839491
    Lot code
    • 38049561
    • 38065517
    • 38092409
    • 38745199
    • 38745480
    • 39092274
    • 40482626
    • 40482629
    • 40497899
    • 40497980
    • 40502330
    • 40504597
    • 40504598
    • 40531426

  8. Direxion Torqueable Microcatheter, NGMC/Fathom/021/BERN/1RO/130; Material Number: M001195640

    UDI-DI
    • 08714729839637
    Lot code
    • 37849390
    • 37914474
    • 37914475
    • 37957745
    • 38022639
    • 38022640
    • 38112640
    • 38181970
    • 38181971
    • 38224584
    • 38259484
    • 38290726
    • 38290727
    • 38290728
    • 38399245
    • 38399246
    • 38399247
    • 38444840
    • 38444841
    • 38444842
    • 38460462
    • 38479512
    • 38484293
    • 38484294
    • 38530458
    • 38530459
    • 38560742
    • 38560752
    • 38708442
    • 38708443
    • 38708444
    • 38708445
    • 38769962
    • 38769963
    • 38769964
    • 38810598
    • 38810599
    • 38810760
    • 38810761
    • 38876169
    • 38916621
    • 38970725
    • 38970726
    • 38970727
    • 38970728
    • 38970732
    • 38970733
    • 38970734
    • 39029800
    • 39074448
    • 40466474
    • 40466590
    • 40466591
    • 40476391
    • 40476392
    • 40476393
    • 40485646
    • 40485726
    • 40485727
    • 40485728
    • 40501045
    • 40501046
    • 40504841
    • 40504842
    • 40507430
    • 40507431
    • 40508310
    • 40508311
    • 40512998
    • 40512999
    • 40513080
    • 40523938
    • 40523939
    • 40524020
    • 40533345
    • 40535978

  9. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130; Material Number: M001195470

    UDI-DI
    • 08714729839545
    Lot code
    • 38112474
    • 38149823
    • 38181962
    • 38181963
    • 38399282
    • 38415919
    • 38416360
    • 38445015
    • 38649840
    • 38649849
    • 39143221
    • 40470762
    • 40470763
    • 40470782
    • 40476387
    • 40476388
    • 40478984
    • 40478985
    • 40502172

  10. Direxion Torqueable Microcatheter, NGMC/Transend/027/STRAIGHT/1RO/130; Material Number: M001195910

    UDI-DI
    • 08714729839828
    Lot code
    • 38240235
    • 38273744
    • 39092271
    • 40464692
    • 40464699
    • 40531397

  11. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155; Material Number: M001195350

    UDI-DI
    • 08714729839460
    Lot code
    • 37881102
    • 37881103
    • 37943142
    • 37943143
    • 37957743
    • 38439681
    • 38439682
    • 38484292
    • 38527325
    • 38876320
    • 38904816
    • 38904817
    • 38916510
    • 38916512
    • 38990272
    • 38990273
    • 38990274
    • 39029898
    • 39092695
    • 39092696

  12. Direxion Torqueable Microcatheter, NGMC/Fathom/027/STRAIGHT/1RO/155; Material Number: M001195720

    UDI-DI
    • 08714729839699
    Lot code
    • 38049560
    • 38092415
    • 38112641
    • 38112642
    • 38181973
    • 38210072
    • 38224586
    • 38224587
    • 38239068
    • 38399299
    • 38595657
    • 38595658
    • 38629568
    • 38650000
    • 40493316
    • 40493317
    • 40495081
    • 40504596
    • 40504689
    • 40504690
    • 40512594
    • 40523965
    • 40525821

  13. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130; Material Number: M001195320

    UDI-DI
    • 08714729839439
    Lot code
    • 37818440
    • 37818441
    • 37981349
    • 38002446
    • 38200316
    • 38200317
    • 38224539
    • 38304087
    • 38330639
    • 38399242
    • 38399243
    • 38503335
    • 38530451
    • 38629573
    • 38629576
    • 38650063
    • 38650068
    • 38810584
    • 38904811
    • 40466632
    • 40466633
    • 40466634
    • 40476310
    • 40476442
    • 40476443
    • 40482607
    • 40482609
    • 40489044
    • 40491252
    • 40493253
    • 40493444
    • 40502171
    • 40502326
    • 40502327
    • 40504735
    • 40504736
    • 40504737
    • 40525535
    • 40531443
    • 40531445
    • 40533244
    • 40533305

  14. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260

    UDI-DI
    • 08714729839378
    Lot code
    • 37818211
    • 37881104
    • 37942459
    • 38002443
    • 38224536
    • 38415913
    • 38595894
    • 38595895
    • 38629331
    • 38687224
    • 38904567
    • 38904568
    • 38916620
    • 38970937
    • 38990576
    • 38990842
    • 39027322

  15. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130; Material Number: M001195410

    UDI-DI
    • 08714729839484
    Lot code
    • 38061296
    • 38092407
    • 38092408
    • 38112473
    • 38149821
    • 38181960
    • 38198831
    • 38224581
    • 38259482
    • 38273746
    • 38362200
    • 38362201
    • 38399244
    • 38445017
    • 38649517
    • 38649853
    • 38667794
    • 38810594
    • 38904807
    • 40470780
    • 40476390
    • 40482606
    • 40493383
    • 40495046
    • 40495047
    • 40495048
    • 40495049
    • 40502037
    • 40502268
    • 40510553
    • 40510554
    • 40512596
    • 40512597
    • 40512990
    • 40516627
    • 40518479
    • 40518820
    • 40518821
    • 40525714
    • 40525715
    • 40525716

  16. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155; Material Number: M001195220

    UDI-DI
    • 08714729839330
    Lot code
    • 37981345
    • 38022666
    • 38629565
    • 38629566
    • 38708453
    • 38745192
    • 38800928
    • 38800929
    • 38916517
    • 38937262
    • 38990881
    • 39074440
    • 39141261
    • 40482690
    • 40482691
    • 40485783
    • 40485784
    • 40489060
    • 40507284
    • 40510556
    • 40512867
    • 40512868
    • 40512869
    • 40512993
    • 40512994
    • 40512995
    • 40513031
    • 40513032
    • 40539143
    • 40539144

  17. Direxion Torqueable Microcatheter, NGMC/Fathom/021/BERN/1RO/155; Material Number: M001195650

    UDI-DI
    • 08714729839644
    Lot code
    • 37886794
    • 37957747
    • 38022670
    • 38049176
    • 38149828
    • 38175798
    • 38224585
    • 38259485
    • 38323409
    • 38506199
    • 38531120
    • 38560457
    • 38595646
    • 38595647
    • 38745191
    • 38769968
    • 38769971
    • 38916516
    • 38970729
    • 38990859
    • 38990882
    • 39027327
    • 39141260
    • 39189845
    • 40466132
    • 40466133
    • 40466134
    • 40485781
    • 40493314
    • 40502331
    • 40502332
    • 40502333
    • 40504594
    • 40507434
    • 40507435
    • 40531377
    • 40535710
    • 40535711
    • 40537146

  18. Direxion Torqueable Microcatheter, NGMC/Fathom/021/BERN/2RO/130; Material Number: M001195670

    UDI-DI
    • 08714729839668
    Lot code
    • 37881100
    • 37889829
    • 37914477
    • 37914478
    • 37914479
    • 37943144
    • 37981351
    • 37981352
    • 38002448
    • 38002449
    • 38002450
    • 38017051
    • 38017052
    • 38022674
    • 38022676
    • 38073300
    • 38073301
    • 38273216
    • 38330740
    • 38350327
    • 38362202
    • 38399248
    • 38399249
    • 38434624
    • 38434625
    • 38439685
    • 38439687
    • 38445013
    • 38560448
    • 38560451
    • 38687322
    • 38810583
    • 38810585
    • 38827798
    • 38827799
    • 38902297
    • 38902298
    • 38916513
    • 38990275
    • 38990276
    • 38990277
    • 39092688
    • 39092689
    • 39143520
    • 39189848
    • 40466136
    • 40466717
    • 40476440
    • 40476441
    • 40492317
    • 40492357
    • 40493443
    • 40507482
    • 40510454
    • 40510455
    • 40510683
    • 40510769
    • 40525862
    • 40531441
    • 40531444

  19. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290

    UDI-DI
    • 08714729839408
    Lot code
    • 38362172
    • 38362173
    • 38530450
    • 38595659

  20. Direxion Torqueable Microcatheter, NGMC/Fathom/021/STRAIGHT/2RO/130; Material Number: M001195660

    UDI-DI
    • 08714729839651
    Lot code
    • 37914476
    • 38629575
    • 38650015
    • 38687321
    • 39029882
    • 39029883
    • 40466020
    • 40466021
    • 40466135
    • 40507481
    • 40510684
    • 40539451

  21. Direxion Torqueable Microcatheter, NGMC/Fathom/027/BERN/1RO/155; Material Number: M001195750

    UDI-DI
    • 08714729839729
    Lot code
    • 38049562
    • 38112644
    • 38112645
    • 38181975
    • 38259489
    • 38273638
    • 38342770
    • 38346223
    • 38399380
    • 38707974
    • 39074174
    • 39074176
    • 39092273
    • 40470667
    • 40476303
    • 40485786
    • 40485787
    • 40493318
    • 40495100
    • 40507439
    • 40512986
    • 40512987
    • 40523966
    • 40524003
    • 40531398
    • 40531399

  22. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130; Material Number: M001195210

    UDI-DI
    • 08714729839323
    Lot code
    • 37914435
    • 37914436
    • 37956674
    • 37981343
    • 37981344
    • 38022632
    • 38022633
    • 38022634
    • 38149673
    • 38181211
    • 38224528
    • 38259475
    • 38259476
    • 38290713
    • 38290714
    • 38290715
    • 38290716
    • 38290717
    • 38399232
    • 38446223
    • 38479515
    • 38506196
    • 38530446
    • 38530447
    • 38629332
    • 38629333
    • 38647617
    • 38647618
    • 38649501
    • 38649508
    • 38687327
    • 38708440
    • 38708441
    • 38745184
    • 38769513
    • 38769514
    • 38934430
    • 39189795
    • 39189798
    • 40466471
    • 40466472
    • 40482683
    • 40482684
    • 40482685
    • 40487838
    • 40487839
    • 40487900
    • 40487954
    • 40487955
    • 40487956
    • 40487957
    • 40501048
    • 40501049
    • 40514122
    • 40514123
    • 40514222
    • 40514223
    • 40533342
    • 40533344
    • 40536165
    • 40536166

  23. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155; Material Number: M001195310

    UDI-DI
    • 08714729839422
    Lot code
    • 37818217
    • 37818218
    • 37818219
    • 37881110
    • 37881111
    • 37881112
    • 37886789
    • 37886790
    • 37886791
    • 37886792
    • 37928860
    • 37928862
    • 38585015
    • 38585016
    • 38745481
    • 38745482
    • 38745483
    • 39143525
    • 39143526
    • 39143527
    • 40466594
    • 40466595
    • 40466596
    • 40476306
    • 40476307
    • 40476308
    • 40482692
    • 40482693
    • 40482694
    • 40485789
    • 40485790
    • 40485791

  24. Direxion Torqueable Microcatheter, NGMC/Transend/021/BERN/1RO/155; Material Number: M001195850

    UDI-DI
    • 08714729839781
    Lot code
    • 37996606
    • 38022677
    • 38022678
    • 38065534
    • 38065535
    • 38112646
    • 38149837
    • 38224591
    • 38259492
    • 38290688
    • 38446231
    • 38769969
    • 38769970
    • 38810249
    • 38875417
    • 38936818
    • 38970730
    • 38970731
    • 38990886
    • 39074178
    • 40466463
    • 40466605
    • 40466606
    • 40470665
    • 40470666
    • 40476198
    • 40484940
    • 40485711
    • 40485712
    • 40485782
    • 40492387
    • 40507437
    • 40512910
    • 40512911
    • 40512912
    • 40512914
    • 40523982
    • 40524002
    • 40525713
    • 40531378
    • 40537147

  25. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240

    UDI-DI
    • 08714729839354
    Lot code
    • 37818206
    • 37818207
    • 37818208
    • 37818209
    • 37849382
    • 37849383
    • 37849384
    • 37849385
    • 37849386
    • 37849387
    • 37849388
    • 37849389
    • 37914437
    • 37914438
    • 37914439
    • 37914460
    • 37914461
    • 37956676
    • 37956677
    • 37981347
    • 38002442
    • 38022635
    • 38022636
    • 38049174
    • 38112465
    • 38112466
    • 38112467
    • 38112468
    • 38112469
    • 38149674
    • 38149675
    • 38149676
    • 38181212
    • 38181213
    • 38181214
    • 38224531
    • 38224532
    • 38224533
    • 38224534
    • 38259477
    • 38259478
    • 38259479
    • 38290718
    • 38290719
    • 38290720
    • 38290721
    • 38290722
    • 38290723
    • 38350139
    • 38350320
    • 38350321
    • 38350322
    • 38350323
    • 38361992
    • 38361993
    • 38361994
    • 38361995
    • 38361996
    • 38399233
    • 38399234
    • 38399235
    • 38399236
    • 38399237
    • 38399238
    • 38479516
    • 38479517
    • 38506194
    • 38530448
    • 38530449
    • 38560743
    • 38560744
    • 38560745
    • 38560746
    • 38560747
    • 38595897
    • 38595898
    • 38595899
    • 38596320
    • 38596321
    • 38629336
    • 38629339
    • 38629560
    • 38649503
    • 38649505
    • 38687328
    • 38687329
    • 38687330
    • 38687331
    • 38701165
    • 38708407
    • 38708408
    • 38708411
    • 38708414
    • 38708417
    • 38708418
    • 38708419
    • 38745186
    • 38745187
    • 38745189
    • 38769518
    • 38769519
    • 38769960
    • 38769961
    • 38810595
    • 38810596
    • 38810597
    • 38827709
    • 38827710
    • 38827711
    • 38827712
    • 38827713
    • 38827714
    • 38827715
    • 38827716
    • 38827717
    • 38904801
    • 38904802
    • 38904803
    • 38932705
    • 38970735
    • 38970736
    • 38990278
    • 38990279
    • 38990341
    • 38990343
    • 38990344
    • 38990345
    • 39029646
    • 39029647
    • 39029648
    • 39029649
    • 39029654
    • 39074444
    • 39074445
    • 39074446
    • 39074452
    • 39074453
    • 39074454
    • 39074455
    • 39074456
    • 39140982
    • 39140983
    • 39140984
    • 39140985
    • 39140986
    • 40466475
    • 40466476
    • 40466477
    • 40466585
    • 40466586
    • 40466587
    • 40482558
    • 40482559
    • 40482680
    • 40482681
    • 40482682
    • 40488088
    • 40488089
    • 40488090
    • 40488091
    • 40501038
    • 40501039
    • 40501080
    • 40501081
    • 40501082
    • 40501083
    • 40504691
    • 40504692
    • 40507428
    • 40507429
    • 40510781
    • 40510782
    • 40510783
    • 40510784
    • 40510785
    • 40514124
    • 40514125
    • 40521990
    • 40521991
    • 40533357
    • 40533358
    • 40533359
    • 40533361
    • 40533363
    • 40533365
    • 40536160
    • 40536161
    • 40536162
    • 40536163
    • 40536164
    • 40539613
    • 40539614
    • 40539615
    • 40539616

  26. Direxion Torqueable Microcatheter, NGMC/Transend/021/BERN/1RO/130; Material Number: M001195840

    UDI-DI
    • 08714729839774
    Lot code
    • 37818448
    • 37818450
    • 37849391
    • 37849392
    • 37849393
    • 37849394
    • 37914481
    • 37914482
    • 37914483
    • 37957749
    • 37957750
    • 37957751
    • 37957752
    • 37981353
    • 37981354
    • 37981355
    • 37981356
    • 38002451
    • 38002452
    • 38002453
    • 38002454
    • 38002455
    • 38002456
    • 38022642
    • 38022643
    • 38022644
    • 38022645
    • 38049173
    • 38065519
    • 38065520
    • 38065522
    • 38065523
    • 38065524
    • 38065525
    • 38065527
    • 38065528
    • 38065529
    • 38065531
    • 38065532
    • 38065533
    • 38106627
    • 38106628
    • 38106630
    • 38149832
    • 38149833
    • 38149834
    • 38149835
    • 38149836
    • 38181976
    • 38181977
    • 38181978
    • 38181979
    • 38181980
    • 38259490
    • 38259491
    • 38290729
    • 38290730
    • 38290731
    • 38290732
    • 38290733
    • 38350328
    • 38350329
    • 38350330
    • 38350331
    • 38350332
    • 38350333
    • 38362203
    • 38362205
    • 38362206
    • 38531121
    • 38629563
    • 38649510
    • 38687335
    • 38708448
    • 38708449
    • 38708450
    • 38708451
    • 38769965
    • 38769966
    • 38769967
    • 38827707
    • 38827708
    • 38876170
    • 38904804
    • 38932706
    • 38932707
    • 38934432
    • 38934433
    • 38934434
    • 39029655
    • 39029656
    • 39029657
    • 39029658
    • 39074458
    • 39074459
    • 39074600
    • 39074601
    • 39074602
    • 39074603
    • 39140987
    • 39140988
    • 39140989
    • 39140990
    • 39140991
    • 39140992
    • 39187842
    • 39187844
    • 39187845
    • 39187846
    • 39219921
    • 40466468
    • 40466469
    • 40466470
    • 40466588
    • 40466589
    • 40466607
    • 40466608
    • 40466609
    • 40466610
    • 40471679
    • 40471960
    • 40471961
    • 40476398
    • 40476480
    • 40476481
    • 40476482
    • 40485645
    • 40485722
    • 40485723
    • 40485724
    • 40485729
    • 40485730
    • 40485731
    • 40493372
    • 40493373
    • 40493374
    • 40493375
    • 40493376
    • 40493377
    • 40493378
    • 40493379
    • 40493380
    • 40493381
    • 40494944
    • 40494945
    • 40494946
    • 40502255
    • 40502258
    • 40502259
    • 40504658
    • 40504659
    • 40504840
    • 40508312
    • 40508313
    • 40510558
    • 40510559
    • 40512915
    • 40512916
    • 40512918
    • 40513100
    • 40513101
    • 40521985
    • 40521986
    • 40521987
    • 40521988
    • 40521989
    • 40523930
    • 40523931
    • 40523932
    • 40523933
    • 40523934
    • 40523935
    • 40523936
    • 40523937
    • 40526446
    • 40526447
    • 40526448
    • 40526449
    • 40526450
    • 40526451
    • 40528687
    • 40528688
    • 40528689
    • 40528690
    • 40528691
    • 40533346
    • 40533347
    • 40533348
    • 40533349
    • 40535973
    • 40535974
    • 40535976
    • 40539619

  27. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280

    UDI-DI
    • 08714729839392
    Lot code
    • 38149679
    • 38323401
    • 38444072
    • 38506482
    • 38506491
    • 38560458
    • 38595645
    • 38810252
    • 38936816
    • 39140997
    • 39141264
    • 39189785
    • 39189791
    • 40482687
    • 40493382
    • 40512909

  28. Direxion Torqueable Microcatheter, NGMC/Transend/021/STRAIGHT/1RO/130; Material Number: M001195810

    UDI-DI
    • 08714729839743
    Lot code
    • 37914480
    • 37957748
    • 38022641
    • 38149831
    • 38224590
    • 38446222
    • 38649514
    • 39074449
    • 39074450
    • 39074451
    • 39187259
    • 39187840
    • 39187841
    • 40476396
    • 40485725
    • 40493312
    • 40504693
    • 40507433
    • 40510780
    • 40513102
    • 40513103

  29. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105; Material Number: M001195400

    UDI-DI
    • 08714729839477
    Lot code
    • 38049178
    • 38415916
    • 38595648
    • 38708403
    • 39141268

  30. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number: M001195230

    UDI-DI
    • 08714729839347
    Lot code
    • 37818205
    • 37942458
    • 37956675
    • 37981346
    • 38002441
    • 38224529
    • 38224530
    • 38304917
    • 38304918
    • 38415912
    • 38484288
    • 38506191
    • 38595896
    • 38629330
    • 38647611
    • 38647613
    • 38687220
    • 38687221
    • 38707976
    • 38876166
    • 38970274
    • 38970936
    • 39092279
    • 39092680
    • 40484896
    • 40484897
    • 40484952
    • 40523918
    • 40523919
    • 40525673
    • 40525674
    • 40525675
    • 40525676
    • 40531394
    • 40531395
    • 40531396

  31. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155; Material Number: M001195510

    UDI-DI
    • 08714729839583
    Lot code
    • 38061601
    • 38063600
    • 38434622
    • 38434623
    • 38650006
    • 38650007
    • 40482630
    • 40482631
    • 40502273
    • 40502274

Recall details

Company began the recall
Sold in

Worldwide distribution US Nationwide and territory of Puerto Rico. The countries of Albania, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Lithuania, Mexico, Moldova, Netherlands, New Zealand, Norway, Panama, PERU, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, T¿rkiye, UAE, United Kingdom.

Company
Boston Scientific Cork, Ltd.
Hazard
Device defect
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
99906
Recall numbers
Z-0223-2027 to Z-0263-2027

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

More medical device recalls

See all: More medical device recalls

Summary by Recall Canary, written with AI · summary updated Oct 23, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)