Medtronic MyCareLink Smart Patient Monitors Recalled for Remote Monitoring Issues
Medtronic is recalling MyCareLink Smart Patient Monitors because patients with multiple implanted heart devices may experience missed remote monitoring alerts.
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 involves a risk-of-harm product (medical device) where the failure to monitor could lead to missed critical alerts, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medtronic Inc. is recalling MyCareLink Smart Patient Monitors, which are portable electronic devices intended to communicate with compatible Medtronic implanted heart devices. 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 monitored on two or more implanted Medtronic heart devices within the Medtronic CareLink Network. This issue could lead to missed CareAlert notifications or device reports.
Patients using these devices should contact Medtronic or their healthcare provider for instructions on how to proceed with monitoring their implanted heart devices.
The recalled product
- 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
- 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 25000
- UPN/GTIN 00643169527546
- 00643169569744
- 00643169666337
- 00643169697843¿
- 00643169862876
- 00643169697850
- 00643169742246
- 00643169862883
- 00643169666375
- 00643169666382
- 00643169666344
- 00643169666351
- 00643169666368
- 00643169666320
- 00643169590397
- 00643169527584
- 00643169527591
- 00643169527553
- 00643169527560
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.
See all 2 products in this recall →Related recalls
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