Recall Z-2125-2016— Medtronic Inc., Cardiac Rhythm and Heart Failure
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure, initiated 2016-05-26, terminated 2016-10-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.. Reason: Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After release, Medtronic identified an issue with the software that prevents implanted device data from being available to clinicians on the CareLink Network. While the transmission appears successful to the patient, the transmitted data, including CareAlerts, are not visible to the clinic..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-05-26
- Terminated
- 2016-10-27
- Firm location
- Mounds View, MN, United States
Product description
Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.
Reason for recall
Recently, a new software version was automatically sent to a subset of Model 24950 MyCareLink Monitors. After release, Medtronic identified an issue with the software that prevents implanted device data from being available to clinicians on the CareLink Network. While the transmission appears successful to the patient, the transmitted data, including CareAlerts, are not visible to the clinic.
Data sourced from openFDA. This site is unofficial and independent of the FDA.