Medtronic CareLink SmartSync Device Manager Recall for Inaccurate Longevity Estimates
Medtronic is recalling CareLink SmartSync Device Manager units 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. The hazard is a software display error that does not impact device functionality, fitting the criteria for moderate severity without reported injuries or hospitalizations.
Plain-English summary
Medtronic Inc. is recalling 874 units of the CareLink SmartSync Device Manager, a programmer and remote monitoring software application. The recall is due to a potential for the software to display an inaccurate remaining longevity estimate for a subset of implanted cardiac device models.
The affected units were distributed worldwide. The source text explicitly states that this issue does not impact device functionality. No specific consumer actions or contact information are provided in the source text.
The recalled product
- Product
- Programmers & Remote Monitoring Software Apps: CareLink SmartSync Device Manager
- Category
- Medical Device — Software
- Hazard
- Affected units
- 874
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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Similar recalls
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FDA (Devices) · 2021-05-12
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