Recalls / —

—#168165

Product

Medtronic CareLink 2090 Programmer

FDA product code

OSR — Pacemaker/Icd/Crt Non-Implanted Components

Device class

Class 3

Medical specialty

Unknown

PMA numbers

P890003S398

Affected lot / code info

All Serial Numbers

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

The firm began disseminating the Field Corrective Action notices by hand delivery on 10/02/2018 and followed with the posting of Medtronic Security Bulletin and the Urgent Medical Device Correction customer letter online on 10/11/2018. The notice explained 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 and beginning October 11th, 2018, Medtronic will be disabling the SDN for programmer updates and will rely solely on the USB update method.

Recalling firm

Firm

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Address

8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391

Distribution

Distribution pattern

Worldwide

Timeline

Recall initiated

2018-10-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #168165. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.