Jan

2018

Cl II MyCareLink Smart Patient Monitors

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl II MyCareLink Smart Patient Monitors

Amy Sellers

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