Medical device recalls Moderate risk

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic CareLink Encore 29901 Programmer

Recall date
October 2, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0407-2019
FDA classification
Class II
Brand / firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Sold / distributed
Worldwide

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medtronic CareLink Encore 29901 Programmer

Get recall alerts

Free email alert whenever Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)