Medtronic Inc. Cardiac Rhythm Disease Management: 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 -50C 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.

Recall number

Z-0149-2012

Recalling firm

Medtronic Inc. Cardiac Rhythm Disease Management

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 -50C 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.

Status

Terminated

Initiated

2011-08-29

Posted

2011-11-02

Terminated

2012-06-07

Reason

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

Root cause

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

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.

Lot, serial or model codes

Model Number: 2AF282 Lot Numbers: 21571, 25375, 25376, 25377, and 25381

510(k) numbers

not on file

PMA numbers

["P100010"]

Product code

OAE

Firm FEI

2182208

Firm city

Saint Paul

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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