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Medtronic Arctic Front Catheter, Sterile EO, Medtronic… recallZ-0149-2012 · Medtronic Inc. Cardiac Rhythm Disease Management · initiated Aug 29, 2011

Terminated All recalls posted in November 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Inc. Cardiac Rhythm Disease Management or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 root cause category: Employee error

What the company is doing

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.

Recall details

Recall number
Z-0149-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 29, 2011
Posted by the FDA
Nov 2, 2011
Recalling firm
Medtronic Inc. Cardiac Rhythm Disease Management
Quantity
263
Product code
OAE
FDA submissions
P100010
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.

Product description

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

22 devices cleared under P100010 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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