Recall Z-1396-2024
Boston Scientific Corporation · initiated March 5, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
OptiCross Coronary Imaging Catheter, REF H749518080120
Codes / lots: UDI/DI 08714729938415, Lot Numbers: 32426901, 32429407, 32625286
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.
FDA-determined 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.
Details
- Recall number
- Z-1396-2024
- Initiated
- March 5, 2024
- Posted by FDA
- March 28, 2024
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Quantity
- 239 units
- Distribution
- International distribution to the country of Japan.
- Recalling firm
- Boston Scientific Corporation, Maple Grove, MN