Medtronic CareLink Encore 29901 Programmer Recalled for Software Vulnerability
Medtronic is recalling CareLink Encore 29901 Programmers worldwide due to a vulnerability that allows unauthorized software updates during SDN downloads.
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 (medical device) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medtronic Inc. is recalling 4,072 units of the CareLink Encore 29901 Programmer. The recall covers units with all serial numbers and affects distribution worldwide.
The recall is due to vulnerabilities identified in the Secure Data Network (SDN) download process. These vulnerabilities may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.
The source text does not specify specific actions for consumers or report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Medtronic CareLink Encore 29901 Programmer
- Affected units
- 4,072
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 vulnerability
See all →- ModerateRevolution CT ES X-ray Computed Tomography System Security Vulnerability Recall
FDA (Devices) · 2026-05-20
- HighPyxis Medication and Anesthesia Dispensing Systems Recalled for Software Vulnerabilities
FDA (Devices) · 2025-02-19
- High
- HighTorrent Suite Dx Software versions affected by cybersecurity vulnerability
FDA (Devices) · 2024-04-10
- ModerateSiemens Lantis 6.1 Commander Recalled for Windows RDP Vulnerability
FDA (Devices) · 2019-08-14
Similar recalls
- HighMedtronic CareLink Encore Programmer Recalled for Cyber Vulnerabilities
FDA (Devices) · 2020-03-25
- ModerateMedtronic CareLink Encore Programmer Recall for Inaccurate Longevity Estimates
FDA (Devices) · 2019-11-06
- ModerateMedtronic CareLink Encore 29901 Programmer Recalled for Usage Restrictions
FDA (Devices) · 2019-02-13
- HighMedtronic Power Supply and Programmer Recall for Electrical Short Risk
FDA (Devices) · 2019-02-27
- HighMedtronic CareLink 2090 Programmer Recalled for Cyber Vulnerabilities
FDA (Devices) · 2020-03-25
- ModerateMedtronic 2090 CareLink Programmer Recall for Inaccurate Longevity Estimates
FDA (Devices) · 2019-11-06