Company:Medtronic Inc., Cardiac Rhythm and Heart Failure
Date of Enforcement Report 1/31/2018
Class lI:

PRODUCT

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
Recall Number Z-0400-2018

REASON
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.

RECALLING FIRM/MANUFACTURER
Medtronic Inc., Cardiac Rhythm and Heart Failure, Mountain View, MN on 7/14/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
1,519,984 enrollments total

DISTRIBUTION
Nationwide and Internationally

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