Medtronic Inc., Cardiac Rhythm and Heart Failure recalls Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitorin…

Recall date

May 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2125-2016

FDA classification

Class II

Brand / firm

Medtronic Inc., Cardiac Rhythm and Heart Failure

Sold / distributed

Worldwide Distribution to Austria, Belgium, China , Czech Republic , Denmark , Finland , France, Germany, Hong Kong, India , Ireland , Israel, Italy , Malaysia, Netherlands, Norway, Poland, Portugal , Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.