FDA Medical Device Recalls (openFDA)
ATS Medical, Inc.: ATS Open Pivot Mechanical Heart Valve
- Recall number
- Z-0634-04
- Recalling firm
- ATS Medical, Inc.
- Product
- ATS Open Pivot Mechanical Heart Valve
- Status
- Terminated
- Initiated
- 2004-02-18
- Posted
- 2004-07-20
- Terminated
- 2005-05-10
- Reason
- Normally functioning prosthesis may have been placed on the valve holder mechanism in reverse position.
- 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
- 56,266
- Distribution
- Nationwide throughout the US and worldwide.
- Lot, serial or model codes
- 500DA, 500FA, 500DM, 501DA, and 501DM. The problem affects all products shipped to the field before January 31, 2002.
- 510(k) numbers
- not on file
- PMA numbers
- ["P990046"]
- Product code
- LWQ
- Firm FEI
- 3008592544
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28