CareLink 2090 Programmer and CareLink Encore 29901 Programmer (2018-10-08)

Starting date:

October 8, 2018

Posting date:

November 2, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68172

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  Reason
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  Affected products

Affected products

1. CareLink 2090 Programmer
2. CareLink Encore 29901 Programmer

Reason

Purpose of this recall is to notify customers regarding modification to improve cybersecurity of device programmers by changing how the programmers are updated with new software. Medtronic will be disabling the SDN for programmer updates and will rely solely on the USB update method. Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with non-Medtronic software during an SDN download. To date, Medtronic has received zero (0) reports to indicate that such an issue has occurred.

Affected products