Recall Z-0849-05 ยท MAF Stent, Coronary
Edwards Lifesciences Llc
Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D)
| Date | May 18, 2005 (initiated Apr 28, 2005) |
| Status | Terminated |
| Reason | Potential for deployment difficulties. |
| Root cause | Other |
| Action | Recall was by voice mail and regular postal service on 4/28/2005 in the USA, in Europe recall began May 2, 2005. Recall notification is complete, unused product is being returned. |
| Quantity | 537 |
| Distribution | Nationwide and Europe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.