ATS Open Pivot Mechanical Heart Valve
FDA device recall Z-0634-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- ATS Medical, Inc.
- Reason for recall
- Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LWQ
- Quantity affected
- 56,266
- Distribution
- Nationwide throughout the US and worldwide.
- Date initiated
- 2004-02-18
- Date posted
- 2004-07-20
- Date terminated
- 2005-05-10
- Location
- Minneapolis, MN
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