Recalls / —
—#168166
Product
Medtronic CareLink Encore 29901 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 #168166. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.