FDA recall Z-0407-2019

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Class II · device

Product

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.

Distribution

Worldwide

Key facts

Status: Ongoing
Initiation date: 2018-10-02
Report date: 2018-11-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0407-2019