Recall Z-1211-2007 ยท MAF Stent, Coronary
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951
| Date | Aug 29, 2007 (initiated Jul 16, 2007) |
| Status | Terminated |
| Reason | The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing. |
| Root cause | Other |
| Action | The firm initiated the recall on 07/16/2007 by sending recall letters with attached Customer Reply form via FedEx to each direct account that received the recalled product. Customers were informed of the issue and given instructions to work with their local account representative to review their inventory, remove the recalled product, complete the Customer Reply form and return the recalled product to Abbott Vascular. |
| Quantity | 43 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.