Medtronic Recalls MyCareLink Patient Monitor Due to Data Transmission Failure
Medtronic is recalling 262 MyCareLink Patient Monitors because a software update prevents implanted device data from reaching clinicians, despite appearing successful to patients.
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 involves a medical device where a software defect prevents critical health data from reaching clinicians, creating a risk of harm due to lack of monitoring, although no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medtronic Inc. is recalling 262 units of the MyCareLink Patient Monitor, Model 24950. This remote monitoring system is designed to interrogate implanted devices and transmit data to the CareLink Network for physician review. The recall was initiated after a new software version was automatically sent to a subset of these monitors.
Medtronic identified an issue with the software that prevents implanted device data, including CareAlerts, from being visible to clinics on the CareLink Network. Although the data transmission appears successful to the patient, the information is not available to clinicians. The affected units were distributed worldwide to 27 countries, including the United Kingdom, Germany, France, and China.
Patients using the affected monitors should contact their healthcare provider or Medtronic for instructions on how to proceed. The recall is limited to specific serial numbers listed in the official FDA notice.
The recalled product
- Product
- Medtronic, MyCareLink Patient Monitor, Model 24950, Rx Only. The MyCareLink Monitor, Model 24950, is a remote monitoring system that interrogates implanted devices and transmits the data to the Care Link Network for viewing by the physician.
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- Affected units
- 262
Distribution
Distribution scope not specified by the agency.
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