International Medical Devices Database

Manufacturer Address
ATS Medical, Inc., 3905 Annapolis Ln N Ste 105, Minneapolis MN 55447-5473
Source
USFDA
2 Events
- Recall of Device Recall SurgiFrost 7 cm CryoSurgical device plus FrostByte Clamp
- Recall of Device Recall ATS Mechanical Heart Valve

2 devices in the database

Device Recall SurgiFrost 7 cm CryoSurgical device plus FrostByte Clamp

Model / Serial
Lot: 50515, 50602, 50609
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide-ATS Medical distirubted devices to hospitals located in the following states IN, KS, MO, TX. There may be other US distributors of this product.
Product Description
CryoCath Frost Byte CryoSurgical Clamp, Model 60FB1, Manufacturer CryoCath Technologies, Inc., Quebec, Canada. The product consists of a cryosurgical probe (SurgiFrost 7 cm) plus Clamp (FrostByte) packaged for use with Cryosurgical console.

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

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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ATS Medical, Inc.

2 devices in the database

Device Recall SurgiFrost 7 cm CryoSurgical device plus FrostByte Clamp

Device Recall ATS Mechanical Heart Valve