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U.S. Department of Health and Human Services

Class 2 Device Recall ATS Mechanical Heart Valve

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  Class 2 Device Recall ATS Mechanical Heart Valve see related information
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
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
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.
Quantity in Commerce 56,266
Distribution Nationwide throughout the US and worldwide.
Total Product Life Cycle TPLC Device Report
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.
PMA Database PMAs with Product Code = LWQ and Original Applicant = MEDTRONIC ATS MEDICAL, INC.
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