medical MODERATE Updated 2018-01-31

Medtronic Inc., Cardiac Rhythm and Heart Failure recalls MyCareLink Smart Patient Monitors. It is intended for use

See all recalls from Medtronic Inc., Cardiac Rhythm and Heart Failure →

Recalled 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

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Hazard / Issue

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.

Issued by

FDA

Affected States: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA
Lot/Code Info: Model 25000, UPN/GTIN 00643169527546, 00643169569744, 00643169666337, 00643169697843¿, 00643169862876, 00643169697850, 00643169742246, 00643169862883, 00643169666375, 00643169666382, 00643169666344, 00643169666351, 00643169666368, 00643169666320, 00643169590397, 00643169527584, 00643169527591, 00643169527553, 00643169527560, 00643169527577, 00643169947108

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for MyCareLink Smart Patient Monitors. →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

View official government recall

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