Recall Z-1483-2023 ยท NTE Temporary Carotid Catheter For Embolic Capture
Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
| Date | May 11, 2023 (initiated Mar 24, 2023) |
| Status | Open, Classified |
| Reason | There is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which include but are not limited to situations of an intra-procedural delay, unplanned percutaneous or surgical intervention, or stroke; while a replacement device is prepared. |
| Root cause | Vendor change control |
| Action | The firm issued an Urgent MEDICAL DEVICE RECALL notice to it consignees on 03/24/2023 by letter. The notice explained the issue and the hazard, and requested the following actions be taken: - Check inventory and isolate the product to avoid use. - Complete and return the response form - Share this letter with others in your facility who need to be made aware of this recall and with any other facility that may have been sent the affected units of product from your facility. If any units of the affected lots are found to be at the other facility, please arrange the return of the units. - Ret |
| Quantity | 283 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220654 | ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire Cordis Corporation, Apr 6, 2022 |