Boston Scientific Corporation medical device recall: Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 99687
- Recall initiated
- Aug 24, 2026
- Classified by FDA
- Sep 23, 2026
- Posted in Enforcement Report
- Sep 30, 2026
- Recalling firm
- Boston Scientific Corporation
- Firm location
- Maple Grove, MN, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Aug 24, 2026. FDA classified it 30 days later, on Sep 23, 2026. Distribution reported by FDA: 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,… Boston Scientific Corporation has 169 recalls in our records.
Recalled products (1)
Z-3214-2026 Class I Ongoing
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
Codes / lots: M001314001 UDI-DI 08714729354826 Batches 74B2500089 74C2600048 74E2500888 74G2500942 74H2500390 74K2400624 74K2500754 74L2400920 M001314011 UDI-DI 08714729354833 Batches 74B2500937 74F2500509 74L2400427 74L2400913 74L2500679 74M2400314 M001314021 UDI-DI 08714729354840 Batches 74A2500370 74C2500582 74E2500889 74E2600070 74G2500421 74H2500875 74K2400982 74K2500755 74L2500841 M001314031 UDI-DI 08714729354857 Batches 74B2501237 74D2600727 74F2500968 74M2400317 M001314041 UDI-DI 08714729354864 Batches 74A2500996 74B2600070 74D2501155 74D2600456 74G2500951 74K2401116 M001314051 UDI-DI 08714729354871 Batches 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…
Quantity: 262,686
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 99687
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.