Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/C

Is my product affected?

Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

• UPC 00643169369030
• UPC 00643169167087
• UPC 00643169225732
• UPC 00643169167025
• UPC 00643169166998
• UPC 00643169166981
• UPC 00643169121973
• UPC 00643169369047

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling the CareLink Encore 29901 Programmer, a device used to interrogate and program Medtronic and Vitatron implantable devices such as pacemakers, ICDs, and cardiac resynchronization therapy devices. The recall affects 5,540 devices distributed worldwide, including across the United States and numerous countries in Central and South America, the Caribbean, Europe, and Japan. The Medtronic Conexus Telemetry system in these programmers contains two primary cyber vulnerabilities: improper access control and cleartext transmission of sensitive information.

The recall record does not specify a remedy or corrective action for affected consumers to take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information. Distribution: 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, Mexico, Jamaica, Japan, Belgium, Greece, Germany, Switzerland, United Kingdom, Spain, Italy, Luxembou Quantity: 5,540 devices Lot/code info: Product Number 29901; All Serial Numbers; Known Model Numbers: a. Model Number 29901, GTIN (Lot Numbers): 00643169369030 (JVD000243P), 00643169369030 (JVD000246P), 00643169369030 (JVD000248P), 00643169369030 (JVD000249P), 00643169369030 (JVD000250P), 00643169369030 (JVD000252P), 00643169369030 (JVD000270P), 00643169369030 (JVD000274P), 00643169369030 (JVD000277P), 00643169369030 (JVD000280P), 00643169369030 (JVD000281P), 00643169369030 (JVD000302P), 00643169369030 (JVD000303P), 00643169167087 (JVD000304P), 00643169369030 (JVD000312P), 00643169369030 (JVD000315P), 00643169167087 (JVD000317P), 00643169369030 (JVD000323P), 00643169369030 (JVD000325P), 00643169369030 (JVD000327P), 00643169369030 (JVD000328P), 00643169369030 (JVD000329P), 00643169369030 (JVD000335P), 00643169369030 (JVD000340P), 00643169369030 (JVD000345P), 00643169369030 (JVD000349P), 00643169369030 (JVD000365P), 00643169369030 (JVD000366P), 00643169369030 (JVD000375P), 00643169369030 (JVD000380P), 00643169369030 (JVD000396P), 00643169369030 (JVD000400P), 00643169369030 (JVD000403P), 00643169369030 (JVD000406P), 00643169369030 (JVD000416P), 00643169369030 (JVD000422P), 00643169369030 (JVD000423P), 00643169369030 (JVD000427P), 00643169369030 (JVD000429P), 00643169369030 (JVD000431P), 00643169369030 (JVD000433P), 00643169369030 (JVD000435P), 00643169369030 (JVD000436P), 00643169369030 (JVD000438P), 00643169369030 (JVD000440P), 00643169369030 (JVD000441P), 00643169369030 (JVD000442P), 00643169369030 (JVD000443P), 00

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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