Recall Z-1396-2024 ยท OBJ Catheter, Ultrasound, Intravascular
Boston Scientific Corporation
OptiCross Coronary Imaging Catheter, REF H749518080120
| Date | Mar 28, 2024 (initiated Mar 5, 2024) |
| Status | Open, Classified |
| Reason | Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness. |
| Root cause | Process control |
| Action | Boston Scientific issued an Urgent Medical Device Removal notice to its consignees on 03/05/2024 via overnight delivery. The notice explained the issue, potential risk, and requested the consignee immediately discontinue use, segregate, and respond pending return of the device. |
| Quantity | 239 units |
| Distribution | International distribution to the country of Japan. |
| FDA record | Open on fda.gov |