Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MyCareLink Smart Patient Monitors. It is intended for use with Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure Due to Patients monitored on two (2) or more implanted...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc., Cardiac Rhythm and Heart Failure directly.
Affected Products
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
Quantity: 1,519,984 enrollments total
Why Was This 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.
Where Was This Sold?
This product was distributed to 11 states: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, DC
About Medtronic Inc., Cardiac Rhythm and Heart Failure
Medtronic Inc., Cardiac Rhythm and Heart Failure has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report