Recall Z-0437-05 ยท NIQ Coronary Drug-Eluting Stent
Cordis Corporation
Polymeric coated stent. Cypher BX Velocity Cardio Sirolimus Stents.
| Date | Jan 26, 2005 (initiated Jan 12, 2005) |
| Status | Terminated |
| Reason | Six of 370 stents released to market had a slightly below the required polymeric coating weight. All other specification were met. |
| Root cause | Other |
| Action | A withdrawal letter is in the process of being hand-delivered to accounts that received this lot, by a Cordis sales representative. Any remaining units from this lot are being removed, and returned to Cordis. The returned units will be scrapped. An Acknowledgement Form is being signed indicating that the account was informed, and documenting whether there is any remaining product from this lot. The withdrawal action was initiated January 12, 2005. |
| Quantity | 300 |
| Distribution | Distributed throughout the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.