WATCHDOG ACCESSORY KIT (20-PACK), UPN H74939343A021 (outer package), UPN H74939343A020 (inner package)
FDA device recall Z-1593-2023 · posted 2023-05-16 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
- Action taken
- Boston Scientific issued an URGENT MEDICAL DEVICE PRODUCT REMOVAL notice on 04/05/2023 by overnight mail. The notice explained the issue and the hazard and requested the consignee segregate the devices pending return. Medical facilities who distributed the devices and distributors were directed to send the notice to their customers.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- DTL
- Quantity affected
- 10833 units
- Distribution
- Worldwide
- Date initiated
- 2023-04-05
- Date posted
- 2023-05-16
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WATCHDOG Hemostasis Valve Kit (K172453) | Boston Scientific Corporation | 2017-11-09 |