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.
What this means for you
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.
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