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Terminated

ATS Open Pivot Mechanical Heart Valve

FDA Recall Z-0634-04 · Posted 2004-07-20

Recalling FirmATS Medical, Inc.
Recall StatusTerminated
Product CodeLWQ
Date Initiated2004-02-18
Date Terminated2005-05-10
Product Quantity56,266

Reason for Recall

Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide throughout the US and worldwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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