Reported Sep 30, 2026 · Ongoing · Updated Oct 6, 2026
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5;…
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
26 of 26 products
| # | Product as published |
|---|---|
| 1 | Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5 |
| 2 | M001314011 IMAGER II/5/ST/100/038 BX5 |
| 3 | M001314021 IMAGER II/5/ST/65/035 BX 5 |
| 4 | M001314031 IMAGER II/5/ST/100/035 BX 5 |
| 5 | M001314041 IMAGER II/5/BARNH/100/038 BX5 |
| 6 | M001314051 IMAGER II/5/BERN/100/038 BX5 |
| 7 | M001314061 IMAGER II/5/BERN/100/035 BX 5 |
| 8 | M001314081 IMAGER II/5/BERN/40/038 BX5 |
| 9 | M001314101 IMAGER II/5/BERN/65/038 BX5 |
| 10 | M001314141 IMAGER II/5/H1/100/038 BX5 |
| 11 | M001314151 IMAGER II/5/H1/100/035 BX 5 |
| 12 | M001314301 IMAGER II/5/SIM1/65/038 BX5 |
| 13 | M001314321 IMAGER II/5/SIM1/100/038 BX5 |
| 14 | M001314341 IMAGER II/5/SIM2/100/038 BX5 |
| 15 | M001314351 IMAGER II/5/SIM2/100/035 BX 5 |
| 16 | M001314361 IMAGER II/5/SIM3/100/038 BX5 |
| 17 | M001314521 IMAGER II/5/CHGB/65/038 BX5 |
| 18 | M001314581 IMAGER II/5/CONTRA 2/65/038 BX5 |
| 19 | M001314621 IMAGER II/5/C1/65/038 BX5 |
| 20 | M001314661 00AGER II/5/C2/65/038 BX5 |
- Lot codes and dates
- M001314001 UDI-DI 08714729354826 BatchesUDI-DI 08714729354833 Batches 74B2500937 74F2500509 74L2400427 74L2400913 74L2500679 74M2400314 M001314021 UDI-DI 08714729354840 Batches
74B250008974C260004874E250088874G250094274H250039074K240062474K250075474L2400920M001314011
UDI-DI 08714729354857 Batches 74B2501237 74D2600727 74F2500968 74M2400317 M001314041 UDI-DI 08714729354864 Batches 74A2500996 74B2600070 74D2501155 74D2600456 74G2500951 74K2401116 M001314051 UDI-DI 08714729354871 Batches74A250037074C250058274E250088974E260007074G250042174H250087574K240098274K250075574L2500841M001314031
UDI-DI 08714729354888 Batches74A250058674A250099774B250009074B250071174B250094074B250123874B260007974B260031074B260039074B260041274B260057374C250104774C260034874C260043074C260053174D250012474D250042474D250115674D260045574D260085774D260111674E250098274E250119474F250051174F250059974F250076874G250042274G250075974G250115374G250134974H250039274H250065974H250066574H250104274J250031874J250055274K240133074K250016474K250075674K250091774L240072074L250003374L250068074M240007274M240030474M240031874M2500245M001314061
UDI-DI 08714729354901 Batches74A250004474A250058774A260026174A260041574B250009174B250048874B260008074B260089574C250005374C250058374C260035074D250012574D250042674D260057574E250020174E250029374E250098174E250119574F250096974G250077874G250135074H250104174J250008574K240062574K250075974L240004174L240041174L240041874L240124874L240125974L250068174L250083174L250093974M240030374M2400305M001314081
UDI-DI 08714729354925 Batches74A250037574A260068174B250048974B260004274B260032874B260032974C250058474D250042774E250029474E250119674E260041274E260041374F250072274G250091074G250094374G250135174H250023474H250103574K240106974L240041974L240068774L250035974L250068274M2400306M001314101
UDI-DI 08714729354963 Batches74A250037674A250046174A260032474A260041774A260068074B260057274B260059074B260084074C250002174C250004674C250058574C260004374C260004474C260053274C260081074D250060474D250068274D260003974D260005074D260057874E250029574E250119774E260007174E260019374E260019474E260087074F250012074F250076774F250097074F260005974F260032874G250047674G250094474H250038374J250017074J250054774K240036174K240107074K240131774K250016574K250103974L240093974L240125074L250036774M240007574M250009274M2500571M001314141
UDI-DI 08714729354970 Batches 74C2500767 74E2600505 74F2500121 74F2500967 74L2401249 M001314301 UDI-DI 08714729355120 Batches74A250108474A260068574B260007874B260057574D260045774G250094574K240111374M2500705M001314151
UDI-DI 08714729355144 Batches74A250046274A260005974B250049074C250076874C260004674C260073374E250029674F250097174F260006274F260032974G250019074H250022374J250008074K240036274L250003274M2500572M001314321
UDI-DI 08714729355168 Batches74A250058874B250049174B250124074B260053974C250076974D260057174F250012274G250019174G250094774H250023574L240125174M2500706M001314341
UDI-DI 08714729355175 Batches74A250058974B250049274B260059174C250077074D250068374D260057274E250029774F250012374G250134574H250023674J250008374K240132174K250075874L240068974M240006574M250008474M250057674M2500708M001314351
UDI-DI 08714729355182 Batches 74F2500125 74M2500709 M001314521 UDI-DI 08714729355342 Batches 74E2500646 M001314581 UDI-DI 08714729355403 Batches74A250059074A260041674B250070874C250077174D250068474E250029874E260050774F250012474G250019274G250134674H250023774K240132274M240006674M240078374M2500242M001314361
UDI-DI 08714729355441 Batches74A250046374A250098874A260033174A260068374A260068474B250070974C250077274C260004574C260070274D250068574E250064774E260007274F250012674F260006074G250019374H250038474J250030574K240061574K240061674K240111774K250104074L240042474L240072174L240093874L240129074L250002974M240073474M2500093M001314621
UDI-DI 08714729355489 Batches74A250099074A250108574A250108774D250068674E250030174E250064874F250012774H250022574J250030674K240061774K250104174L240072274L240091574L240125374L250037074M2400078M001314661
UDI-DI 08714729355496 Batches74A250099374A250131174A260006174A260068274B250049374B250071074C250004774C250077374C260053374D250068774D250088174D260057974E250064974F250012874F250050374G250019474H250022674H250038574J250008674J250030774K240061874K250016674K250104274L240091674L240125474L250002174L250037174L250068374M240006774M240007974M2500573M001314671
UDI-DI 08714729355588 Batches74A250011174A250131274A260005874C250004874C250103974C260053074D250088274D260057774E250065074F250050474G250019574H250038674J250030874K240061974K240111474K250116574M240006874M2500574M001314761
UDI-DI 08714729355595 Batches74A250131374C250077474E250065174E250088274F260006174G250022474K2500753M001314771
UDI-DI 08714729355649 Batches74A250131474C250004974C260070374D250003874D250088374E250088374E260050874E260086974F250050574F260005874G250033374H250087374J250031674J250054974L240042674L250068974M2400069M001314821
UDI-DI 08714729355687 Batches 74C2500051 74L2400936 74M2500086 M001314881 UDI-DI 08714729355700 Batches 74E2500884 74G2500226 74G2500334 74J2500311 74K2400620 74L250002274A260070274B250008274B260031174C250005074C250104174F250050674K250016374L2400937M001314861
- M001314001 UDI-DI 08714729354826 Batches
- Amount recalled
- 262,686
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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