OptiCross Coronary Imaging Catheter, REF H749518080120
FDA device recall Z-1396-2024 · posted 2024-03-28 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- OBJ
- Quantity affected
- 239 units
- Distribution
- International distribution to the country of Japan.
- Date initiated
- 2024-03-05
- Date posted
- 2024-03-28
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD (K213593) | Boston Scientific Corporation | 2022-01-14 |
| OPTICROSS 40 MHZ CORONARY IMAGING CATHETER (K123621) | Boston Scientific Corp | 2013-04-15 |