Recall Z-1257-2021 ยท NIM Stent, Carotid
Cordis Corporation
PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC
| Date | Feb 11, 2021 |
| Status | Completed |
| Reason | Distal tip may become separated from the lumen wire in specific lots. |
| Root cause | Process control |
| Action | The firm initiated the recall by letter on 02/11/2021. The letter explained the reason for recall and potential impact to the patient, along with the request to further disseminate the notices and return of the recalled units. |
| Quantity | 18218 units |
| Distribution | US (except MT and NM) and Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.