Medtronic Inc., Cardiac Rhythm and Heart Failure recalls MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The mo…

Recall date

July 14, 2017

Source

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

Recall number

Z-0399-2018

FDA classification

Class II

Brand / firm

Medtronic Inc., Cardiac Rhythm and Heart Failure

Sold / distributed

Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Internationally: Austria, Belgium, Brunei, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lithuania, Malaysia, Malta, Netherlands, Norway,…

Why it was recalled

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.

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

What was recalled

MyCareLink Patient Monitors. It is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or clinician.