Medtronic CareLink 2090 Programmer Recalled for Software Vulnerability
Medtronic is recalling CareLink 2090 Programmers worldwide due to a vulnerability that allows unauthorized software updates during the SDN download process.
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 is classified as FDA Class II and involves a security vulnerability in a medical device that poses a risk of harm, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Medtronic Inc. is recalling the Medtronic CareLink 2090 Programmer. The recall involves 30,172 units distributed worldwide, covering all serial numbers. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is being issued because vulnerabilities were identified in the SDN download process. These vulnerabilities may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download.
Healthcare providers and patients using the Medtronic CareLink 2090 Programmer should contact Medtronic for instructions on how to address the software vulnerability.
The recalled product
- Product
- Medtronic CareLink 2090 Programmer
- Affected units
- 30,172
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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