Medtronic Programmers Recalled for Longevity Estimation Error
Medtronic is recalling 2090 Carelink and 29901 Encore programmers due to a potential longevity estimation error in specific pacing configurations.
What this means for you
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 does not report any hospitalizations, injuries, or deaths. The hazard is a software estimation error rather than a direct physical safety failure, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Inc. is recalling the 2090 Carelink and 29901 Encore programmers. These devices are used to treat arrhythmias related to bradycardia and provide cardiac resynchronization therapy (CRT) for heart failure. The recall involves 37,690 units distributed worldwide.
The recall is due to a potential longevity estimation error that may occur in the early years of device life. This error specifically occurs 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.
Consumers and healthcare providers should contact Medtronic for further instructions regarding the affected programmers.
The recalled product
- Product
- Programmers - 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. 1. 2090 Carelink 2. 29901 Encore
- Hazard
- Affected units
- 37,690
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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