Recall Z-0149-2012 ยท OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
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 ins
| Date | Nov 2, 2011 (initiated Aug 29, 2011) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.