FDAJuly 14, 2017device

MyCareLink Smart Patient Monitors. It is intended for use with a compatible Medtronic patient implanted heart device. The reader is a portable electronic device that communicates with an implanted heart device

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.

What to do

FDA enforcement status: Terminated

Brands named

medtronic inc cardiac rhythm and heart failuremedtronicmedtronic inc

UPCs

006431695275460064316956974400643169666337006431696978430064316986287600643169697850006431697422460064316986288300643169666375006431696663820064316966634400643169666351

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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