Medtronic CareLink Encore Programmer Recall for Inaccurate Longevity Estimates
Medtronic is recalling 6,713 CareLink Encore Programmer units worldwide because they may display inaccurate remaining longevity estimates for certain implanted cardiac devices. The issue does not impact device functionality.
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, but the source text explicitly states that the issue does not impact device functionality and no injuries or illnesses are reported, fitting the criteria for a moderate severity recall involving a non-functional defect.
Plain-English summary
Medtronic Inc. is recalling 6,713 units of the 29901 CareLink Encore Programmer, a device used for programming and remote monitoring of cardiac devices. The units were distributed worldwide.
The recall is due to a potential for the programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models. The source text explicitly states that this issue does not impact device functionality.
Consumers and healthcare providers should check if their device serial number is on the affected list provided by Medtronic. If the device is affected, they should contact Medtronic for further instructions on how to proceed.
The recalled product
- Product
- Programmers & Remote Monitoring Software Apps: 29901 CareLink Encore Programmer
- Hazard
- Affected units
- 6,713
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) 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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