PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: March 25, 2020 Initiated: January 30, 2020 #Z-1524-2020

Product Description

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

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.

Details

Units Affected
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, Mexico, Jamaica, Japan, Belgium, Greece, Germany, Switzerland, United Kingdom, Spain, Italy, Luxembourg, Poland, Austria, Suriname, Netherlands, Aruba, Hungary, Liechtenstein, Sweden, Czech Republic, Ireland, France, French Polynesia, New Caledonia, Guadeloupe, Reunion, Mauritius, Kenya, South Africa, Uganda, Namibia, Finland, Norway, Portugal, Iceland, Denmark, Faroe Islands, Greenland, Macedonia, Iraq, Pakistan, Sudan, Jordan, Morocco, Belarus, Lebanon, Sri Lanka, Kazakhstan, Bulgaria, Egypt, Turkey, Libya, Serbia, Tunisia, Cyprus, Oman, Slovenia, Algeria, Malta, Croatia, Saudi Arabia, Syria, Kuwait, Latvia, Ukraine, Andorra, Burkina Faso, Nepal, Mayotte, French Guiana, Martinique, Bosnia And Herzegovina, Qatar, United Arab Emirates, Georgia, Yemen, Slovakia, Iran, Canada, Lithuania, United States, Cote D'Ivoire, Nicaragua, Zimbabwe, Azerbaijan, Albania, Ghana, India, Israel, Guam, American Samoa, Korea, Armenia, Mozambique, Nigeria, Bangladesh, Australia, Taiwan, Cambodia, Hong Kong, Malaysia, Viet Nam, Singapore, New Zealand, Indonesia, Philippines, Angola, Rwanda, Northern Mariana Islands, Senegal, Cameroon, Botswana,Russian Federation, Montenegro, China, Turkmenistan, St. Maarten, Tanzania, Kyrgyzstan, Netherlands Antilles, Cuba, Romania, Mongolia, Kosovo, Tajikistan, Benin, Ethiopia, Moldova, Afghanistan, Democratic Republic of Congo, and Thailand
Location
Mounds View, MN

Frequently Asked Questions

What product was recalled?
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.. Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 23,180 devices.
Why was this product recalled?
Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitive information.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 25, 2020. Severity: Moderate. Recall number: Z-1524-2020.