Maquet Percutaneous Insertion Kits and Guidewires
The packaging may not consistently maintain sterile barrier integrity.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Maquet Cardiopulmonary GmbH is recalling Percutaneous Insertion Kits because the packaging may not consistently maintain sterile barrier integrity. The kits include the Guidewire 150 cm, Guidewire 100 cm, and dilator set L models. The recall began on July 31, 2026, and was added to the FDA's Enforcement Report on September 11, 2026. Distribution is worldwide, including the US nationwide and many other countries.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Affected if its UDI-DI and lot code are listed under that product.
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
- UDI-DI
- 701053069
- 4037691730677
- 3000324478
- 3000326922
- 3000336965
- 3000339840
- 3000347863
- 3000370471
- 3000374104
- 3000379854
- 3000382443
- 3000395582
- 3000403657
- 3000414517
- 3000430804
- 3000434603
- 3000444269
- 3000445982
- 3000453327
- 3000466026
- Lot
- 3000471522
- 3000476322
- 3000476324
- 3000479560
- 3000485154
- 3000491022
- 3000496205
- 3000503935
- 3000510431
- 3000511851
- 3000518007
- 3000520749
- 3000525464
- 3000528231
- 3000534008
- 3000324481
- 3000324482
- 3000324483
- 3000326924
- 3000326926
- 3000326927
- 3000326928
- 3000328824
- 3000328825
- 3000328826
- 3000328827
- 3000328828
- 3000331194
- 3000331195
- 3000331196
- 3000331197
- 3000331198
- 3000331199
- 3000331225
- 3000333814
- 3000333815
- 3000333816
- 3000333817
- 3000333818
- 3000334775
- 3000334776
- 3000334777
- 3000334778
- 3000334779
- 3000336028
- 3000336029
- 3000336030
- 3000336031
- 3000336032
- 3000336033
- 3000338092
- 3000338093
- 3000338094
- 3000338095
- 3000338096
- 3000339833
- 3000339834
- 3000339835
- 3000339836
- 3000339837
- 3000341453
- 3000341454
- 3000341455
- 3000341456
- 3000342415
- 3000342416
- 3000342417
- 3000342418
- 3000342419
- 3000342420
- 3000342421
- 3000342422
- 3000343894
- 3000343895
- 3000343896
- 3000343897
- 3000343898
- 3000343899
- 3000343900
- 3000343901
- 3000345720
- 3000345721
- 3000345722
- 3000345723
- 3000345724
- 3000345725
- 3000345726
- 3000345727
- 3000345728
- 3000345729
- 3000347867
- 3000347868
- 3000347869
- 3000347870
- 3000349429
- 3000349430
- 3000349431
- 3000349432
- 3000349434
- 3000350476
- 3000350477
- 3000350478
- 3000350479
- 3000351515
- 3000351516
- 3000351517
- 3000351518
- 3000351951
- 3000351952
- 3000351953
- 3000351954
- 3000353376
- 3000353377
- 3000353378
- 3000353379
- 3000353380
- 3000354958
- 3000354959
- 3000354960
- 3000356336
- 3000356337
- 3000356338
- 3000356339
- 3000357758
- 3000357759
- 3000357760
- 3000359472
- 3000359473
- 3000359474
- 3000359476
- 3000363549
- 3000363550
- 3000369079
- 3000369080
- 3000369265
- 3000369266
- 3000369317
- 3000369318
- 3000369320
- 3000370467
- 3000370468
- 3000370469
- 3000370470
- 3000372386
- 3000372387
- 3000372388
- 3000372389
- 3000373780
- 3000373781
- 3000373782
- 3000373783
- 3000374102
- 3000374103
- 3000375675
- 3000375676
- 3000377476
- 3000377477
- 3000377478
- 3000378520
- 3000378521
- 3000378522
- 3000378523
- 3000379857
- 3000379858
- 3000379859
- 3000382446
- 3000382447
- 3000382448
- 3000382449
- 3000384008
- 3000384009
- 3000384012
- 3000384013
- 3000384018
- 3000385169
- 3000385171
- 3000385172
- 3000385173
- 3000387896
- 3000387897
- 3000387898
- 3000387899
- 3000389001
- 3000389002
- 3000389003
- 3000389004
- 3000389005
- 3000390764
- 3000390765
- 3000390766
- 3000390767
- 3000392517
- 3000392518
- 3000392519
- 3000392521
- 3000392523
- 3000393469
- 3000393471
- 3000393472
- 3000395577
- 3000395578
- 3000395579
- 3000395580
- 3000397025
- 3000397027
- 3000397028
- 3000397029
- 3000397033
- 3000397034
- 3000398275
- 3000398786
- 3000398787
- 3000398788
- 3000400244
- 3000400245
- 3000400246
- 3000400247
- 3000400248
- 3000400249
- 3000404886
- 3000404887
- 3000404888
- 3000404889
- 3000404890
- 3000406842
- 3000406846
- 3000406847
- 3000406849
- 3000408180
- 3000408181
- 3000408182
- 3000408183
- 3000408184
- 3000408185
- 3000410261
- 3000410262
- 3000410263
- 3000410264
- 3000411200
- 3000412146
- 3000412642
- 3000412643
- 3000413597
- 3000413598
- 3000413599
- 3000413600
- 3000414520
- 3000414521
- 3000414522
- 3000414523
- 3000414524
- 3000417082
- 3000417083
- 3000417084
- 3000417085
- 3000417086
- 3000417087
- 3000418479
- 3000418480
- 3000418481
- 3000418482
- 3000420376
- 3000420377
- 3000420378
- 3000423668
- 3000423669
- 3000423671
- 3000423672
- 3000423673
- 3000424270
- 3000424271
- 3000424272
- 3000424273
- 3000424274
- 3000425770
- 3000425771
- 3000425772
- 3000425773
- 3000431822
- 3000431823
- 3000431824
- 3000431825
- 3000431826
- 3000431827
- 3000431828
- 3000434599
- 3000434600
- 3000434601
- 3000434602
- 3000438012
- 3000438013
- 3000441388
- 3000441389
- 3000441824
- 3000444275
- 3000444276
- 3000444277
- 3000444718
- 3000444719
- 3000444720
- 3000444721
- 3000445645
- 3000445646
- 3000445647
- 3000445648
- 3000445978
- 3000445979
- 3000445980
- 3000445981
- 3000448173
- 3000448174
- 3000448175
- 3000448176
- 3000448177
- 3000449727
- 3000449728
- 3000449729
- 3000449730
- 3000451984
- 3000451985
- 3000451986
- 3000451987
- 3000451988
- 3000453331
- 3000453332
- 3000455124
- 3000455125
- 3000455126
- 3000455127
- 3000458528
- 3000458529
- 3000458530
- 3000458531
- 3000458532
- 3000461212
- 3000461213
- 3000461214
- 3000461215
- 3000461217
- 3000464623
- 3000464624
- 3000464625
- 3000464626
- 3000466030
- 3000466031
- 3000466032
- 3000466033
- 3000468423
- 3000468424
- 3000468425
- 3000471528
- 3000471529
- 3000471530
- 3000471531
- 3000471536
- 3000471541
- 3000471542
- 3000471544
- 3000475595
- 3000475596
- 3000475597
- 3000477179
- 3000477180
- 3000477181
- 3000478746
- 3000478747
- 3000478748
- 3000478749
- 3000478836
- 3000479564
- 3000479565
- 3000479567
- 3000481004
- 3000481005
- 3000481006
- 3000481945
- 3000481946
- 3000481947
- 3000481948
- 3000484178
- 3000484179
- 3000484180
- 3000484181
- 3000485143
- 3000486784
- 3000486785
- 3000486786
- 3000488308
- 3000488309
- 3000488310
- 3000489895
- 3000489896
- 3000490871
- 3000490874
- 3000491430
- 3000491431
- 3000491432
- 3000491433
- 3000493065
- 3000493066
- 3000493067
- 3000493068
- 3000496199
- 3000496200
- 3000496201
- 3000496202
- 3000496203
- 3000498673
- 3000498674
- 3000498834
- 3000501303
- 3000501304
- 3000501305
- 3000501307
- 3000502840
- 3000502841
- 3000502843
- 3000502844
- 3000503939
- 3000503942
- 3000503943
- 3000510425
- 3000510426
- 3000510427
- 3000511848
- 3000511849
- 3000511850
- 3000513501
- 3000513502
- 3000513503
- 3000513504
- 3000513505
- 3000514609
- 3000514610
- 3000514611
- 3000514612
- 3000515696
- 3000515697
- 3000515698
- 3000515699
- 3000517998
- 3000518004
- 3000518005
- 3000519528
- 3000519529
- 3000519530
- 3000519531
- 3000519532
- 3000520745
- 3000520746
- 3000520747
- 3000520748
- 3000522411
- 3000522412
- 3000522413
- 3000522414
- 3000522415
- 3000523510
- 3000523511
- 3000524539
- 3000524540
- 3000524541
- 3000525039
- 3000525040
- 3000525041
- 3000525042
- 3000525043
- 3000525460
- 3000525461
- 3000525462
- 3000525463
- 3000526919
- 3000526920
- 3000526921
- 3000526922
- 3000528714
- 3000528715
- 3000528716
- 3000530042
- 3000530043
- 3000530044
- 3000530045
- 3000534004
- 3000534005
- 3000534006
- 3000535444
- 3000535445
- 3000535446
- 3000535447
- 3000537045
- 3000537046
- 3000537047
- 3000537048
- 3000539525
- 3000539526
- 3000539527
- 3000539528
- 3000541228
- 3000541229
- 3000541230
- 3000541231
- 3000541232
- 3000543979
- 3000543986
- 3000543989
- 3000547001
- 3000547002
- 3000547003
- 3000547004
- 3000549189
- 3000549190
- 3000549191
- 3000550936
- 3000550937
- 3000550938
- 3000550939
- 3000553331
- 3000553332
- 3000553333
- 3000553334
- 3000553335
- 3000554727
- 3000554729
- 3000554730
- 3000556412
- 3000556413
- 3000556414
- 3000556415
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
- UDI-DI
- 701053068
- 4037691519883
- 3000324477
- 3000333824
- 3000336037
- 3000341450
- 3000343893
- 3000377475
- 3000387891
- 3000403656
- 3000414516
- 3000430803
- 3000441821
- 3000453326
- 3000471523
- 3000476321
- 3000485151
- 3000496204
- 3000510428
- 3000518006
- Lot
- 3000554731
- 3000324479
- 3000324480
- 3000328829
- 3000328830
- 3000328831
- 3000331203
- 3000331204
- 3000331206
- 3000331224
- 3000333819
- 3000333820
- 3000334780
- 3000334781
- 3000334782
- 3000336034
- 3000336035
- 3000338097
- 3000338098
- 3000339838
- 3000339839
- 3000341457
- 3000341458
- 3000342412
- 3000342413
- 3000343902
- 3000343903
- 3000347872
- 3000347873
- 3000349433
- 3000350472
- 3000350473
- 3000350474
- 3000351949
- 3000351950
- 3000353375
- 3000354955
- 3000354956
- 3000354957
- 3000356333
- 3000356334
- 3000356335
- 3000357761
- 3000357762
- 3000359475
- 3000364061
- 3000364062
- 3000369310
- 3000369312
- 3000369316
- 3000372382
- 3000372383
- 3000373778
- 3000373779
- 3000374100
- 3000375677
- 3000375678
- 3000375679
- 3000378518
- 3000378519
- 3000379856
- 3000382445
- 3000384006
- 3000385167
- 3000385168
- 3000387892
- 3000387893
- 3000390768
- 3000392520
- 3000393467
- 3000393468
- 3000397030
- 3000398789
- 3000400250
- 3000404891
- 3000404892
- 3000408177
- 3000408178
- 3000408179
- 3000410260
- 3000413601
- 3000413602
- 3000414518
- 3000414519
- 3000417088
- 3000418477
- 3000418478
- 3000420374
- 3000420375
- 3000423667
- 3000423674
- 3000425774
- 3000431820
- 3000431821
- 3000434595
- 3000434596
- 3000434597
- 3000434598
- 3000438009
- 3000438010
- 3000441823
- 3000444273
- 3000444274
- 3000445644
- 3000445976
- 3000445977
- 3000448171
- 3000448172
- 3000449726
- 3000451983
- 3000453329
- 3000453330
- 3000455122
- 3000455123
- 3000461218
- 3000461219
- 3000466034
- 3000466035
- 3000468419
- 3000468420
- 3000468421
- 3000471524
- 3000471525
- 3000471526
- 3000471527
- 3000475598
- 3000477178
- 3000477182
- 3000478745
- 3000478834
- 3000479561
- 3000479563
- 3000481002
- 3000481003
- 3000481944
- 3000485139
- 3000485141
- 3000486782
- 3000486787
- 3000488306
- 3000488307
- 3000489894
- 3000491429
- 3000493064
- 3000496195
- 3000498672
- 3000501301
- 3000501302
- 3000502838
- 3000502839
- 3000503938
- 3000504934
- 3000504935
- 3000506575
- 3000506576
- 3000507640
- 3000507642
- 3000508153
- 3000522416
- 3000522469
- 3000523507
- 3000523508
- 3000525035
- 3000525036
- 3000525037
- 3000525038
- 3000525457
- 3000525458
- 3000525459
- 3000526917
- 3000526918
- 3000528230
- 3000528713
- 3000530040
- 3000533974
- 3000534003
- 3000535434
- 3000537044
- 3000539529
- 3000539530
- 3000539531
- 3000543967
- 3000547000
- 3000549187
- 3000549188
- 3000550935
- 3000553328
- 3000553329
- 3000554725
- 3000554726
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
- UDI-DI
- 701054427
- 4037691746517
- 3000324476
- 3000326923
- 3000331200
- 3000333822
- 3000353373
- 3000359477
- 3000364060
- 3000373784
- 3000379853
- 3000393466
- 3000403658
- 3000413596
- 3000434593
- 3000444270
- 3000449725
- 3000453328
- 3000478750
- 3000524542
- Lot
- 3000333821
- 3000341452
- 3000349478
- 3000356330
- 3000370472
- 3000387894
- 3000389007
- 3000395576
- 3000411197
- 3000418475
- 3000438011
- 3000441822
- 3000461221
- 3000466027
- 3000468435
- 3000471532
- 3000485149
- 3000489899
- 3000501535
- 3000508513
- 3000518008
- 3000525465
- 3000526923
- 3000534009
- 3000539532
- 3000541224
Details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom;
- Event ID
- 99668
- Recall numbers
- Z-3144-2026 to Z-3146-2026
- Company
- Maquet Cardiopulmonary GmbhRastatt, Germany
- Hazard
- Sterility failure
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
