FDA recall Z-1524-2020

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Class II · device

Product

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.

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

Key facts

Status
Ongoing
Initiation date
2020-01-30
Report date
2020-03-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1524-2020