FDA-Device2018-11-14Class II

Medtronic CareLink Encore 29901 Programmer

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

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.

Sold states
Worldwide
Affected count
4072 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Medtronic CareLink Encore 29901 Programmer

Official notice

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

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief