FDA Device

Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200

Hazard

PTCA balloon catheter contains a pressure gauge that does not accurately reflect the pressure of the balloon

What You Should Do

Remedy

Medtronic AVE notified the two distributors in Japan on 1/31/2003 who will notify the sales representative to retrieve product from the hospital accounts.Product will be returned to Danvers, accounted and scrapped.

Products

Medtronic AVE Everest PTCA Inflation Catheter 20 cc Item #AC2200
Brand
Medtronic, Inc.
UPC
Lot Numbers: 122851, 12852, 122853

Units Affected

602 units