The Recall Desk

FDA (Devices) recall action 84944

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled 2 products on 2020-03-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-03-25
Critical
0
Units
28,720

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2020-03-25

    Medtronic CareLink 2090 Programmer Recalled for Cyber Vulnerabilities

    Medtronic is recalling 23,180 CareLink 2090 Programmer devices worldwide due to improper access control and cleartext transmission of sensitive information.

    Product
    Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2020-03-25

    Medtronic CareLink Encore Programmer Recalled for Cyber Vulnerabilities

    Medtronic is recalling CareLink Encore 29901 programmers due to improper access control and cleartext transmission of sensitive information.

    Product
    Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.
    Category
    Distribution
    5 states