> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Medtronic HeartWare HVAD System Recall is Class 1
- URL: https://www.fdaweb.com/medtronic-heartware-hvad-system-recall-is-class-1/
- Published: 2021-05-12T12:00:00.000Z
- Updated: 2026-09-14T16:58:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149306

FDA says the Medtronic 2/26 recall of the instructions for use and patient manual for its HeartWare HVAD (HeartWare Ventricular Assist Device) system is Class 1\. An agency [announcement](https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-inc-recalls-instructions-use-and-patient-manual-heartware-hvad-system-update-information?ref=fdaweb.com) says Medtronic recalled the system to provide updated instructions for use and patient manual due to safety issues with the carrying cases, driveline cover orientation, and controller power-up sequence. FDA says there have been one death and 64 injuries reported to the agency for the issues.