Z-0634-04

ATS Open Pivot Mechanical Heart Valve

Name: Z-0634-04 ATS Open Pivot Mechanical Heart Valve
Creator: ATS Medical, Inc.
Published: 2004-02-18
License: https://open.fda.gov/license/

Medtronic, Inc. (Minneapolis, MN 55447) / initiated 2004-02-18 / Terminated

FDA source

ATS Medical, Inc. began a recall of ATS Open Pivot Mechanical Heart Valve on 2004-02-18. The reason FDA records is "Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0634-04
Status: Terminated
Initiated: 2004-02-18
Posted: 2004-07-20
Terminated: 2005-05-10
Recalling firm: Medtronic, Inc. (Minneapolis, MN 55447)
Product: ATS Open Pivot Mechanical Heart Valve
Product code: LWQ Heart-Valve, Mechanical
Reason for recall: Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.
FDA root cause: 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.
Product codes and lots: 500DA, 500FA, 500DM, 501DA, and 501DM. The problem affects all products shipped to the field before January 31, 2002.

Product code LWQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)