Public recall detail

Medtronic Heartware Ventricular Assist Device System - Recall Due to Risk of Neurological Adverse Events, Mortality and Delay or Failure to Restart

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Recall Safety notice
Quick summary

Quick summary: Medtronic Heartware Ventricular Assist Device System - Recall Due to Risk of Neurological Adverse Events, Mortality and Delay or Failure to Restart .

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Medtronic Heartware Ventricular Assist Device System - Recall Due to Risk of Neurological Adverse Events, Mortality and Delay or Failure to Restart .

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

Brand

Issue

On June 3, 2021, the Medtronic HVADTM System was recalled due to an increase in neurological adverse events and mortality, as well as a potential for the internal pump of the Medtronic HVADTM System to delay or fail to restart. Medtronic is now communicating additional instructions as a follow-up to a Recall Notice posted on June 9, 2021.

Additional official information
AudienceHealthcare professionals in hospitals including cardiothoracic surgeons, intensive care physicians, critical care nurses, and others who use Heartware Ventricular Assist Device (HVADTM) System.
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AudiencesHealthcare professionals in hospitals including cardiothoracic surgeons, intensive care physicians, critical care nurses, and others who use Heartware Ventricular Assist Device (HVADTM) System.

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