Recall Z-1525-2020— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Ongoing
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2020-01-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.. 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
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2020-01-30
- Firm location
- Mounds View, MN, United States
Product description
Medtronic CareLink Encore 29901 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.