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.
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 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- CriticalMedtronic CRT-D Defibrillators: Rare Energy Output Failure Risk During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillators Recalled for Reduced Therapy Output
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
Same hazard · software error
See all →- HighQuantum Rehab R-TRAK Powered Wheelchair Controller Recalled Due to Software Issue
FDA (Devices) · 2026-08-12
- HighDASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results
FDA (Devices) · 2026-08-12
- HighQuantum Outback Powered Wheelchair Controller Recalled Due to Unexpected Braking Risk
FDA (Devices) · 2026-08-12
- HighREMISOL Advance Software Version 2.5 Recalled for Incorrect Test Result Reporting
FDA (Devices) · 2026-08-12
- HighQuantum Rehab Q6 Edge 3 Powered Wheelchair Controller Recalled for Unexpected Braking
FDA (Devices) · 2026-08-12