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High RiskFDAfda-Z-1524-2020SOFTWARE DEFECT

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

Units Affected
23,180
Recall Date
January 30, 2020
Issuing Agency
Hazard
Software Defect

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1524-2020.

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

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1524-2020.

Recall ongoing. Follow firm instructions.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf) or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1524-2020.

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

FDA

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Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf) Recall FAQ

Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf) is the subject of a medical implants safety report: Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as pacemaker/ICD/CRT.. The notice was published on January 30, 2020 by the U.S. Food and Drug Administration (FDA). Approximately 23,180 units are potentially affected.