Recall Z-1524-2020 ยท OSR Pacemaker/Icd/Crt Non-Implanted Components
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
| Date | Jan 30, 2020 |
| Status | Open, Classified |
| Reason | Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information. |
| Root cause | Software design |
| Action | Medtronic initially notified customers on about 03/21/2019 via a "Security Bulletin" regarding vulnerabilities to the proprietary Medtronic Conexus radio frequency wireless telemetry protocols associated with some Medtronic ICDs (implantable cardioverter defibrillators) and CRT-Ds (cardiac resynchronization therapy defibrillators). On about 01/30/2020, Medtronic notified customers with affected programmers of the field corrective action notification via 2-day UPS delivery of the consignee letter. On 21 March 2019, Medtronic posted a Security Bulletin regarding the vulnerabilities. Custome |
| Quantity | 23,180 devices |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.