Recall Z-2777-2015 ยท LPB Cardiac Ablation Percutaneous Catheter
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
| Date | Sep 17, 2015 (initiated Sep 1, 2015) |
| Status | Terminated |
| Reason | An issue with a USB memory component contained within a subset of CryoConsoles can result in extended procedure time. |
| Root cause | Component design/selection |
| Action | Medtronic began hand delivering an Urgent Medical Device Correction letter on September 1, 2015, to all affected customers. The letter described the issue. Customers were advised to continue using the device, per the operator's manual, and if a system notice appears, they are to carefully read and follow the instructions in the screen of the console. Medtronic personnel will track contact with the customer via Customer Contact Record. Customers with qeustions were instructed to contact their Medtronic AF Solutions representative. For questions regarding this recall call 1-877-464-2796 Tec |
| Quantity | 103 units |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Algeria, Australia, France, Germany, Greece, Iceland, Ireland, Israel, Italy, Lebanon, Malaysia, Martinique, Netherlands, Poland, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.