Recall Z-0634-04 ยท LWQ Heart-Valve, Mechanical
ATS Medical, Inc.
ATS Open Pivot Mechanical Heart Valve
| Date | Jul 20, 2004 (initiated Feb 18, 2004) |
| Status | Terminated |
| Reason | Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position. |
| Root cause | Other |
| Action | Notification is being made by ATS Medical representatives hand delivery of notification letters dated February 18, 2004 to consignees. Representatives will identify and inspect inventory and return any defective product to ATS Medical. The letter will be signed and returned to verify notification. |
| Quantity | 56,266 |
| Distribution | Nationwide throughout the US and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.