Recall – Implantable device programmer cybersecurity vulnerabilities

Company: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Date of Enforcement Report: 3/25/2020
Class II

PRODUCT

Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.

  • Recall Number: Z-1524-2020

REASON

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

RECALLING FIRM/MANUFACTURER

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on 1/30/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

23,180 devices

DISTRIBUTION

US Nationwide and International

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.