Company:Medtronic Inc.
Date of Enforcement Report 12/7/11
Class ll:
PRODUCT
Medtronic Arctic Front Catheter, Sterile EO, Model 2AF282 and 2AF231 ( not distributed in US) Product Usage: The Medtronic CryoCath System consists of a Cryoablation console, cardiac Cryoablation catheters, connection components and accessories. The Arctic Front Cardiac Cryoablation Catheter is an over the wire Balloon catheter. The inside of the Balloon at the distal end of the Cryoablation Catheter reaches temperatures of -50 C or colder when refrigerant is injected from the console to the inside of the balloon. Arctic Front Cardiac Cryoablation catheters are introduced into the vasculature by traditional minimally invasive techniques. The CryoConsole houses the electrical and mechanical components as well as proprietary software for controlling and recording a cryotherapy procedure with Arctic Front and/or the Freezor family of catheters. It stores and controls the delivery of the liquid refrigerant through the coaxial umbilical to the catheter, recovers the refrigerant vapor from the catheter under constant vacuum, and disposes of the refrigerant through the hospital scavenging system. Multiple features are built into the catheter and the CryoConsole system to ensure safety. Model Number: 2AF282. Recall # Z-0149-2012.
REASON
Product distributed with incorrect programming that may result in false expired catheter notifications..
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Disease Management, Saint Paul, MN, by letter dated August 2011, hand delivered by Medtronic Field Representatives on August 29, 2011.
Manufacturer: Medtronic CryoCath LP, Kirkland, Canada. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
263 units
DISTRIBUTION
Nationwide, Austria, United Kingdom
