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.
What this means for you
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 implanted
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- 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
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.
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