Device Recall ATS Mechanical Heart Valve

Model / Serial
500DA, 500FA, 500DM, 501DA, and 501DM. The problem affects all products shipped to the field before January 31, 2002.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
Yes
Distribution
Nationwide throughout the US and worldwide.
Product Description
ATS Open Pivot Mechanical Heart Valve
Manufacturer
ATS Medical, Inc.
1 Event
- Recall of Device Recall ATS Mechanical Heart Valve

Manufacturer

ATS Medical, Inc.

Manufacturer Address
ATS Medical, Inc., 3905 Annapolis Ln N Ste 105, Minneapolis MN 55447-5473
Source
USFDA

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