Medtronic CareLink Encore 29901 Programmer
- Recall Initiated
- October 2, 2018
- Recall Number
- Z-0407-2019
- Quantity
- 4072 units
- Firm Location
- Mounds View, MN
Reason for Recall
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.
Distribution
Worldwide
Lot / Code Info
All Serial Numbers
Root Cause
Software design
Action Taken
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.