The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0399-2018·Announced 2018-01-31

Medtronic MyCareLink Patient Monitors Recalled for Remote Monitoring Issues

Medtronic is recalling MyCareLink Patient Monitors because patients with multiple implanted heart devices may experience missed remote monitoring notifications.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential but unconfirmed adverse outcomes.

Plain-English summary

Medtronic Inc. is recalling MyCareLink Patient Monitors, which are external electronic devices used to transmit data from compatible Medtronic implanted heart devices to physicians. The recall affects 1,519,984 total enrollments distributed domestically across the United States and internationally in numerous countries.

The recall is due to a potential impact on the ability to remotely monitor patients who are enrolled with two or more implanted Medtronic heart devices in the Medtronic CareLink Network. This issue may lead to missed CareAlert notifications or device reports, potentially affecting the timeliness of clinical monitoring.

Patients using these monitors should contact their healthcare provider or Medtronic for guidance on alternative monitoring methods or device replacement. The recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
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…
Manufacturer
Medtronic Inc., Cardiac Rhythm and Heart Failure
Category
Medical Device — Cardiac Monitoring
Hazard
Affected units
1,519,984

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Model (UPN/GTIN): 24950 (00643169292284
  • 00643169292345
  • 00643169292260
  • 00643169292529
  • 00643169292208
  • 00643169292192
  • 00643169292222
  • 00643169292239
  • 00643169292321
  • 00643169292215
  • 00643169292246
  • 00643169409132
  • 00643169292253
  • 00643169292277
  • 00643169292291
  • 00643169292307
  • 00643169292314
  • 00643169292338)
  • 24950D (643169467163
  • 00643169441484

Distribution

Distributed in 11 states:

Part of a larger recall action

This product is one of 2 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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