Medtronic Recalls CareLink SmartSync Device Manager for Longevity Error
Medtronic is recalling 16,311 CareLink SmartSync Device Manager units worldwide due to a potential longevity estimation error when specific pacing vectors are programmed.
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 no other device features are impacted and does not report any illnesses or injuries. This aligns with the rubric for moderate severity, representing a potential issue without reported harm.
Plain-English summary
Medtronic Inc. is recalling 16,311 units of the CareLink SmartSync Device Manager, Model Number 24970A, due to a potential longevity estimation error. The device is used to treat arrhythmias related to bradycardia and can provide cardiac resynchronization therapy (CRT) in the treatment of heart failure.
The recall is limited to a specific software or calculation issue where a longevity estimation error may occur in the early years of device life. This error is triggered when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. The source text states that no other device features or therapies are impacted by this issue.
The affected units were distributed worldwide. The source text does not specify any reported illnesses, injuries, or deaths associated with this recall. Consumers and healthcare providers should contact Medtronic for further instructions on how to address this longevity estimation error.
The recalled product
- Product
- CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resynchronization therapy (CRT) in treatment of heart failure, Model Number 24970A
- Affected units
- 16,311
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 (1)
- all codes
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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