ATS Open Pivot Mechanical Heart Valve recallZ-0634-04 · ATS Medical, Inc. · initiated Feb 18, 2004
Terminated All recalls posted in July 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ATS Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0634-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 18, 2004
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- ATS Medical, Inc.
- Quantity
- 56,266
- Product code
- LWQ
- FDA submissions
- P990046
- Distribution
- Nationwide throughout the US and worldwide.
Product description
ATS Open Pivot Mechanical Heart Valve
Code information (models, lots, serial numbers)
500DA, 500FA, 500DM, 501DA, and 501DM. The problem affects all products shipped to the field before January 31, 2002.
Other devices under the same FDA submission
42 devices cleared under P990046 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Open Pivot™ 505DA20Medtronic, Inc. · HEART-VALVE, MECHANICAL1 death13 reports
- Open Pivot™ 500DM29Medtronic, Inc. · HEART-VALVE, MECHANICAL11 reports
- Open Pivot™ 505DA24Medtronic, Inc. · HEART-VALVE, MECHANICAL1 death9 reports
- Open Pivot™ 500DM27Medtronic, Inc. · HEART-VALVE, MECHANICAL1 death8 reports
- Open Pivot™ 505DA18Medtronic, Inc. · HEART-VALVE, MECHANICAL7 reports
- Open Pivot™ 505DA20Medtronic, Inc. · HEART-VALVE, MECHANICAL5 reports
- Open Pivot™ 505DA22Medtronic, Inc. · HEART-VALVE, MECHANICAL5 reports
- Open Pivot™ 500DM33Medtronic, Inc. · HEART-VALVE, MECHANICAL1 death5 reports
- Open Pivot™ 505DA22Medtronic, Inc. · HEART-VALVE, MECHANICAL5 reports
- Open Pivot™ 500DM25Medtronic, Inc. · HEART-VALVE, MECHANICAL1 death5 reports
- Open Pivot™ 500DM27Medtronic, Inc. · HEART-VALVE, MECHANICAL4 reports
- Open Pivot™ 505DM26Medtronic, Inc. · HEART-VALVE, MECHANICAL2 deaths4 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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