ATS Medical, Inc. ATS Open Pivot Mechanical Heart Valve Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ATS Open Pivot Mechanical Heart Valve
Brand
ATS Medical, Inc.
Lot Codes / Batch Numbers
500DA, 500FA, 500DM, 501DA, and 501DM. The problem affects all products shipped to the field before January 31, 2002.
Products Sold
500DA, 500FA, 500DM, 501DA, and 501DM. The problem affects all products shipped to the field before January 31, 2002.
ATS Medical, Inc. is recalling ATS Open Pivot Mechanical Heart Valve due to Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026