Recall Z-3214-2026 ยท DQO Catheter, Intravascular, Diagnostic
Boston Scientific Corporation
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 BX
| Date | Sep 23, 2026 (initiated Aug 24, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | Firm began notifying customers on August 24, 2026. Customers were instructed to immediately stop further use or distribution and segregate affected product. Customers should continue to follow the standard of care when monitoring patients treated with the product. Customers were advised to utilize both inner and outer packaging UPN codes when searching for affected product. Customers were provided with instructions to return product. |
| Quantity | 262,686 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121694 | IMAGER II ANGIOGRAPHIC CATHETER Boston Scientific Corp, Sep 14, 2012 |