Recall Z-2209-2010 ยท NVZ Pulse Generator, Permanent, Implantable
Medtronic Inc. Cardiac Rhythm Disease Managment
Medtronic Carelink Monitor Model 2490C. The Medtronic CareLink Monitor Model 2490C is designed to automatically gather information from the implanted heart device. This automatic wireless communication between the heart device and the monitor takes place at times scheduled by the doctor or clinic. The gathered heart device information is sent over a telephone line to the clinic using a toll-free n
| Date | Aug 11, 2010 (initiated Jun 11, 2010) |
| Status | Terminated |
| Reason | Medtronic has identified that a subset of 2490C CareLink Monitors recently received an incorrect software update. Patients reported that their monitor was making a "ticking sound" and they were unable to transmit device data via CareLink. These monitors are now non-functional. No patient injuries have been reported as a result of this issue. |
| Root cause | Software change control |
| Action | Starting on 6/11/2010, Medtronic began sending Australian and Canadian consignees "Medical Device Recall" letters dated 6/10/2010. The letters describe the problem and product involved. The letters instructs consignees to order replacement monitors, notify affected patients, and instruct each patient to perform a manual transmission upon receipt of the new monitor. Medtronic will provide affected patients with a prepaid return kit to faciliate the return of the monitor to Medtronic. Australian consignees should contact Scott Dunlop at 61-7 3025-3547. Canadian consignees should contact Medtr |
| Quantity | 37 Foreign, 0 Domestic |
| Distribution | International Distribution Only: Australia and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.