PlainRecalls
FDA Devices Moderate Class II Ongoing

Medtronic CareLink Encore 29901 Programmer

Reported: November 14, 2018 Initiated: October 2, 2018 #Z-0407-2019

Product Description

Medtronic CareLink Encore 29901 Programmer

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.

Details

Units Affected
4072 units
Distribution
Worldwide
Location
Mounds View, MN

Frequently Asked Questions

What product was recalled?
Medtronic CareLink Encore 29901 Programmer. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 4072 units.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 14, 2018. Severity: Moderate. Recall number: Z-0407-2019.