Recall Z-1592-2023 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Boston Scientific Corporation
WATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
| Date | May 16, 2023 (initiated Apr 5, 2023) |
| Status | Open, Classified |
| Reason | The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 1300 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172453 | WATCHDOG Hemostasis Valve Kit Boston Scientific Corporation, Nov 9, 2017 |