Medical device recalls Moderate risk

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic CareLink 2090 Programmer

Recall date
October 2, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0406-2019
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 2090 Programmer

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