ATS Medical, Inc.

Lot: 50515, 50602, 50609

General and Plastic Surgery Devices

2

No

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.

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.

500DA, 500FA, 500DM, 501DA, and 501DM. The problem affects all products shipped to the field before January 31, 2002.

Cardiovascular Devices

3

Yes

Nationwide throughout the US and worldwide.

ATS Open Pivot Mechanical Heart Valve