Medtronic Recalls CareLink SmartSync Device Manager Due to Software Error
Medtronic is recalling 16,311 CareLink SmartSync Device Managers because a software issue may overestimate the remaining battery life of implanted cardiac devices.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where a software error could lead to delayed replacement of cardiac devices, but no injuries or illnesses have been reported.
Plain-English summary
Medtronic Inc. is recalling 16,311 CareLink SmartSync Device Manager units (model 24970A) distributed worldwide. These devices are used by healthcare professionals to interrogate cardiac implantable electronic devices (CIEDs).
The recall is due to a software issue that can cause the device to overestimate the displayed longevity of the implanted devices. This error may occur during an approximate six-month window before the implanted device triggers its Recommended Replacement Time (RRT).
Healthcare providers using these devices should contact Medtronic for further instructions on how to address the software issue.
The recalled product
- Product
- CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).
- 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 serial numbers
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same manufacturer · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
See all →- SevereImplantable Defibrillators Risk Therapy Failure Due to Feedthrough Defect
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Defibrillators Recalled for Potential Therapy Delivery Failure
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy
FDA (Devices) · 2023-06-28
- SevereMedtronic Implantable Cardioverter Defibrillator may lose energy output during therapy
FDA (Devices) · 2023-06-28
- SevereImplantable Cardioverter Defibrillators at Risk of Reduced Energy Output
FDA (Devices) · 2023-06-28
Same hazard · software error
See all →- ModerateBeckman Coulter DxC 500 AU Clinical Chemistry Analyzers Recalled for Software Error
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter AU480 Chemistry Analyzer Software Error Recall
FDA (Devices) · 2026-10-07
- HighBard EnCor EnCompass Breast Biopsy System Software Recall
FDA (Devices) · 2026-10-07
- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighPhilips EPIQ Elite Ultrasound System Recalled for Software Error
FDA (Devices) · 2026-09-30
Similar recalls
- ModerateMedtronic CareLink SmartSync Device Manager Recall for Inaccurate Longevity Estimates
FDA (Devices) · 2019-11-06
- ModerateMedtronic Recalls CareLink SmartSync Device Manager Due to Feature Suspension
FDA (Devices) · 2020-07-15
- ModerateMedtronic Recalls CareLink SmartSync Device Manager for Longevity Error
FDA (Devices) · 2021-05-12
- ModerateMedtronic 2090 CareLink Programmer Recall for Inaccurate Longevity Estimates
FDA (Devices) · 2019-11-06
- ModerateMedtronic CareLink Encore Programmer Recall for Inaccurate Longevity Estimates
FDA (Devices) · 2019-11-06
- HighMedtronic Cardiac Device Software Affected by Data Processing Error
FDA (Devices) · 2021-12-01