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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic CryoCath Arctic Front CryoAblation Catheter

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 Class 2 Recall
Medtronic CryoCath Arctic Front CryoAblation Catheter
see related information
Date Posted November 02, 2011
Recall Status1 Terminated on June 07, 2012
Recall Number Z-0149-2012
Recall Event ID 60034
Premarket Approval
PMA Number
P100010
Product Classification Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation - Product Code OAE
Product Medtronic Arctic Front Catheter, Sterile EO, Medtronic CryoCath LP, Kirkland, Quebec, H9H 5 H3, Canada, 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.
Code Information Model Number: 2AF282 Lot Numbers: 21571, 25375, 25376, 25377, and 25381
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E.
Saint Paul, Minnesota 55112
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Medtronic CryoCath has identified specific lots of Arctic Front CryoAblation Catheters that were distributed with incorrect programming that may result in false expired catheter notifications. Impacted lots are 21571, 25375, 25376, 25377, and 25381 of the Arctic Front Catheter Model Number 2AF282. Medtronic CryoCath is communicating this information to the FDA. On affected catheters, the incor
FDA Determined
Cause 2
TRAINING: Employee Error
Action Medtronic sent an "Important Device Recall" letter dated August 2011, hand delivered by Medtronic Field Representatives on August 29, 2011 to all affected customers. The letter described the product affected, the problem, and the actions needed to be taken. The customers were instructed to return all unused catheters from affected lots for credit and replacement. The letter states that Medtronic AF Solution representative will assist customers with the return of affected product. For further questions contact your local Medtronic AF Solutions representative.
Quantity in Commerce 263
Distribution Worldwide Distribution - USA (nationwide) including the states of: AK, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MN, MS, MO, NE, NY, NC, OH, OK, PA, SC, SD, TN, TX, VA, WA, and WI. and the countries of: Austria, United Kingdom.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = OAE and Applicant = MEDTRONIC CRYOCATH LP
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