Medical device recalls Moderate risk

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as…

Recall date
January 30, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1524-2020
FDA classification
Class II
Brand / firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Sold / distributed
Worldwide distribution. US Nationwide including Puerto Rico, Argentina, Brazil, Colombia, Trinidad and Tobago, Venezuela, Dominican Republic, Bahamas, Peru, Bermuda, Barbados, Ecuador, Cayman Islands, Curacao, Guatemala, Honduras, Panama, El Salvador, Costa Rica, Bolivia, Chile, Uruguay, Paraguay,…

Why it was recalled

Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.

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. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

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