Imager II Angiographic Catheters
Imager II Angiographic Catheters may fracture or detach, leading to device fragments remaining or migrating.
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
What happened
Boston Scientific Corporation is recalling Imager II Angiographic Catheters because the tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism. The recall began on August 24, 2026, and was added to the FDA's Enforcement Report on September 23, 2026.
The catheters were distributed nationwide in the U.S. and internationally, including Puerto Rico 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?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Product details
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5;
M001314011 IMAGER II/5/ST/100/038 BX5;
M001314021 IMAGER II/5/ST/65/035 BX 5;
M001314031 IMAGER II/5/ST/100/035 BX 5;
M001314041 IMAGER II/5/BARNH/100/038 BX5;
M001314051 IMAGER II/5/BERN/100/038 BX5;
M001314061 IMAGER II/5/BERN/100/035 BX 5;
M001314081 IMAGER II/5/BERN/40/038 BX5;
M001314101 IMAGER II/5/BERN/65/038 BX5;
M001314141 IMAGER II/5/H1/100/038 BX5;
M001314151 IMAGER II/5/H1/100/035 BX 5;
M001314301 IMAGER II/5/SIM1/65/038 BX5;
M001314321 IMAGER II/5/SIM1/100/038 BX5;
M001314341 IMAGER II/5/SIM2/100/038 BX5;
M001314351 IMAGER II/5/SIM2/100/035 BX 5;
M001314361 IMAGER II/5/SIM3/100/038 BX5;
M001314521 IMAGER II/5/CHGB/65/038 BX5;
M001314581 IMAGER II/5/CONTRA 2/65/038 BX5;
M001314621 IMAGER II/5/C1/65/038 BX5;
M001314661 00AGER II/5/C2/65/038 BX5;
M001314671 IMAGER II/5/C2/65/035 BX 5;
M001314761 IMAGER II/5/MIK/65/038 BX5;
M001314771 IMAGER II/5/MIK/65/035 BX 5;
M001314821 IMAGER II/5/SHK1.0/65/038 BX5;
M001314861 IMAGER II/5/RC2/65/038 BX5;
M001314881 IMAGER II/5/RDC/65/038 BX5- UDI-DI
- 08714729354826
- 08714729354833
- 08714729354840
- 08714729354857
- 08714729354864
- 08714729354871
- 08714729354888
- 08714729354901
- Lot
- 74B2500089
- 74C2600048
- 74E2500888
- 74G2500942
- 74H2500390
- 74K2400624
- 74K2500754
- 74L2400920
- M001314011
- 74B2500937
- 74F2500509
- 74L2400427
- 74L2400913
- 74L2500679
- 74M2400314
- M001314021
- 74A2500370
- 74C2500582
- 74E2500889
- 74E2600070
- 74G2500421
- 74H2500875
- 74K2400982
- 74K2500755
- 74L2500841
- M001314031
- 74B2501237
- 74D2600727
- 74F2500968
- 74M2400317
- M001314041
- 74A2500996
- 74B2600070
- 74D2501155
- 74D2600456
- 74G2500951
- 74K2401116
- M001314051
- 74A2500586
- 74A2500997
- 74B2500090
- 74B2500711
- 74B2500940
- 74B2501238
- 74B2600079
- 74B2600310
- 74B2600390
- 74B2600412
- 74B2600573
- 74C2501047
- 74C2600348
- 74C2600430
- 74C2600531
- 74D2500124
- 74D2500424
- 74D2501156
- 74D2600455
- 74D2600857
- 74D2601116
- 74E2500982
- 74E2501194
- 74F2500511
- 74F2500599
- 74F2500768
- 74G2500422
- 74G2500759
- 74G2501153
- 74G2501349
- 74H2500392
- 74H2500659
- 74H2500665
- 74H2501042
- 74J2500318
- 74J2500552
- 74K2401330
- 74K2500164
- 74K2500756
- 74K2500917
- 74L2400720
- 74L2500033
- 74L2500680
- 74M2400072
- 74M2400304
- 74M2400318
- 74M2500245
- M001314061
- 74A2500044
- 74A2500587
- 74A2600261
- 74A2600415
- 74B2500091
- 74B2500488
- 74B2600080
- 74B2600895
- 74C2500053
- 74C2500583
- 74C2600350
- 74D2500125
- 74D2500426
- 74D2600575
- 74E2500201
- 74E2500293
- 74E2500981
- 74E2501195
- 74F2500969
- 74G2500778
- 74G2501350
- 74H2501041
- 74J2500085
- 74K2400625
- 74K2500759
- 74L2400041
- 74L2400411
- 74L2400418
- 74L2401248
- 74L2401259
- 74L2500681
- 74L2500831
- 74L2500939
- 74M2400303
- 74M2400305
- M001314081
- 74A2500375
- 74A2600681
- 74B2500489
- 74B2600042
- 74B2600328
- 74B2600329
- 74C2500584
- 74D2500427
- 74E2500294
- 74E2501196
- 74E2600412
- 74E2600413
- 74F2500722
- 74G2500910
- 74G2500943
- 74G2501351
- 74H2500234
- 74H2501035
- 74K2401069
- 74L2400419
- 74L2400687
- 74L2500359
- 74L2500682
- 74M2400306
- M001314101
- 74A2500376
- 74A2500461
- 74A2600324
- 74A2600417
- 74A2600680
- 74B2600572
- 74B2600590
- 74B2600840
- 74C2500021
- 74C2500046
- 74C2500585
- 74C2600043
- 74C2600044
- 74C2600532
- 74C2600810
- 74D2500604
- 74D2500682
- 74D2600039
- 74D2600050
- 74D2600578
- 74E2500295
- 74E2501197
- 74E2600071
- 74E2600193
- 74E2600194
- 74E2600870
- 74F2500120
- 74F2500767
- 74F2500970
- 74F2600059
- 74F2600328
- 74G2500476
- 74G2500944
- 74H2500383
- 74J2500170
- 74J2500547
- 74K2400361
- 74K2401070
- 74K2401317
- 74K2500165
- 74K2501039
- 74L2400939
- 74L2401250
- 74L2500367
- 74M2400075
- 74M2500092
- 74M2500571
- M001314141
- 74A2501084
- 74A2600685
- 74B2600078
- 74B2600575
- 74D2600457
- 74G2500945
- 74K2401113
- 74M2500705
- M001314151
- 74C2500767
- 74E2600505
- 74F2500121
- 74F2500967
- 74L2401249
- M001314301
- 74A2500462
- 74A2600059
- 74B2500490
- 74C2500768
- 74C2600046
- 74C2600733
- 74E2500296
- 74F2500971
- 74F2600062
- 74F2600329
- 74G2500190
- 74H2500223
- 74J2500080
- 74K2400362
- 74L2500032
- 74M2500572
- M001314321
- 74A2500588
- 74B2500491
- 74B2501240
- 74B2600539
- 74C2500769
- 74D2600571
- 74F2500122
- 74G2500191
- 74G2500947
- 74H2500235
- 74L2401251
- 74M2500706
- M001314341
- 74A2500589
- 74B2500492
- 74B2600591
- 74C2500770
- 74D2500683
- 74D2600572
- 74E2500297
- 74F2500123
- 74G2501345
- 74H2500236
- 74J2500083
- 74K2401321
- 74K2500758
- 74L2400689
- 74M2400065
- 74M2500084
- 74M2500576
- 74M2500708
- M001314351
- 74A2500590
- 74A2600416
- 74B2500708
- 74C2500771
- 74D2500684
- 74E2500298
- 74E2600507
- 74F2500124
- 74G2500192
- 74G2501346
- 74H2500237
- 74K2401322
- 74M2400066
- 74M2400783
- 74M2500242
- M001314361
- 74F2500125
- 74M2500709
- M001314521
- 74E2500646
- M001314581
- 74A2500463
- 74A2500988
- 74A2600331
- 74A2600683
- 74A2600684
- 74B2500709
- 74C2500772
- 74C2600045
- 74C2600702
- 74D2500685
- 74E2500647
- 74E2600072
- 74F2500126
- 74F2600060
- 74G2500193
- 74H2500384
- 74J2500305
- 74K2400615
- 74K2400616
- 74K2401117
- 74K2501040
- 74L2400424
- 74L2400721
- 74L2400938
- 74L2401290
- 74L2500029
- 74M2400734
- 74M2500093
- M001314621
- 74A2500990
- 74A2501085
- 74A2501087
- 74D2500686
- 74E2500301
- 74E2500648
- 74F2500127
- 74H2500225
- 74J2500306
- 74K2400617
- 74K2501041
- 74L2400722
- 74L2400915
- 74L2401253
- 74L2500370
- 74M2400078
- M001314661
- 74A2500993
- 74A2501311
- 74A2600061
- 74A2600682
- 74B2500493
- 74B2500710
- 74C2500047
- 74C2500773
- 74C2600533
- 74D2500687
- 74D2500881
- 74D2600579
- 74E2500649
- 74F2500128
- 74F2500503
- 74G2500194
- 74H2500226
- 74H2500385
- 74J2500086
- 74J2500307
- 74K2400618
- 74K2500166
- 74K2501042
- 74L2400916
- 74L2401254
- 74L2500021
- 74L2500371
- 74L2500683
- 74M2400067
- 74M2400079
- 74M2500573
- M001314671
- 74A2500111
- 74A2501312
- 74A2600058
- 74C2500048
- 74C2501039
- 74C2600530
- 74D2500882
- 74D2600577
- 74E2500650
- 74F2500504
- 74G2500195
- 74H2500386
- 74J2500308
- 74K2400619
- 74K2401114
- 74K2501165
- 74M2400068
- 74M2500574
- M001314761
- 74A2501313
- 74C2500774
- 74E2500651
- 74E2500882
- 74F2600061
- 74G2500224
- 74K2500753
- M001314771
- 74A2501314
- 74C2500049
- 74C2600703
- 74D2500038
- 74D2500883
- 74E2500883
- 74E2600508
- 74E2600869
- 74F2500505
- 74F2600058
- 74G2500333
- 74H2500873
- 74J2500316
- 74J2500549
- 74L2400426
- 74L2500689
- 74M2400069
- M001314821
- 74A2600702
- 74B2500082
- 74B2600311
- 74C2500050
- 74C2501041
- 74F2500506
- 74K2500163
- 74L2400937
- M001314861
- 74C2500051
- 74L2400936
- 74M2500086
- M001314881
- 74E2500884
- 74G2500226
- 74G2500334
- 74J2500311
- 74K2400620
- 74L2500022
Details
- Company began the recall
- Sold in
Worldwide - US Nationwide and territories of Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Barbados, Belgium, Brazil, Brunei Dar-es-S, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Poland, Portugal, Puerto Rico, Qatar, Rep N Macedonia, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad, Tobago, Tunisia, T¿rkiye, UAE, Ukraine, United Kingdom, USA, W. Bank Gaza Strip, Yemen.
- Event ID
- 99687
- Recall No.
- Z-3214-2026
- Company
- Boston Scientific CorporationMaple Grove, Minnesota
- Hazard
- Device defect
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
