Date Initiated by Firm | February 18, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on May 10, 2005 |
Recall Number | Z-0634-04 |
Recall Event ID |
28356 |
PMA Number | P990046 |
Product Classification |
Heart-Valve, Mechanical - Product Code LWQ
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Product | ATS Open Pivot Mechanical Heart Valve |
Code Information |
500DA, 500FA, 500DM, 501DA, and 501DM. The problem affects all products shipped to the field before January 31, 2002. |
Recalling Firm/ Manufacturer |
ATS Medical, Inc. 3905 Annapolis Ln N Ste 105 Minneapolis MN 55447-5473
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Manufacturer Reason for Recall | Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position. |
FDA Determined Cause 2 | 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.
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Quantity in Commerce | 56,266 |
Distribution | Nationwide throughout the US and worldwide. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = LWQ
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