OptiCross Coronary Imaging Catheter, REF H749518080120
This recall is currently active, issued March 28, 2024. It was issued by Boston Scientific Corporation.
- Company
- Boston Scientific Corporation
- Recall Initiated
- March 5, 2024
- Posted
- March 28, 2024
- Recall Number
- Z-1396-2024
- Quantity
- 239 units
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Distribution
International distribution to the country of Japan.
Lot / Code Info
UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286
Root Cause
Process control
Action Taken
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.