Medtronic CareLink Monitors Recalled for Firmware Dial-Up Configuration Error
Medtronic is recalling CareLink and CareLink Express monitors because a firmware update contained incorrect dial-up configuration data, potentially preventing data transmission to the CareLink Network.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity where the product may cause temporary or medically reversible health consequences. The defect is a software configuration error affecting data transmission rather than a direct physical hazard like fire or shock, and no injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Inc. is recalling 5,038 units of the CareLink Monitor (2490C) and CareLink Express Monitor (2020B). These remote monitoring systems are used to interrogate implanted cardiac devices and transmit data to physicians via the CareLink Network.
The recall is due to a firmware update that included incorrect data in the country analog modem dial-up configuration table. This error resulted in the removal of the necessary '0' prefix for select countries and an incorrect alignment of phone numbers for other select countries, which may prevent the monitors from successfully dialing into the network.
The affected units were distributed in Austria, Australia, Belgium, Switzerland, Germany, Denmark, France, Great Britain, Hungary, Japan, Netherlands, New Zealand, Poland, Portugal, and Sweden. Consumers should contact Medtronic for instructions on how to resolve the issue.
The recalled product
- Product
- Medtronic CareLink" Monitor (2490C) and Medtronic CareLink Express" Monitor (2020B) Product Usage: The 2490C CareLink Home Monitors and 2020B CareLink Express Monitors are remote monitoring systems that interrogate implanted devices and transmit the data to Medtronic s…
- Manufacturer
- Medtronic Inc., Cardiac Rhythm and Heart Failure
- Affected units
- 5,038
Distribution
Distribution scope not specified by the agency.
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