FDAMay 26, 2016device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
medtronic inc cardiac rhythm and heart failuremedtronicmedtronic inc
Recall history
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