The FDA is providing updated information on Medtronic's HeartWare Ventricular Assist Device (HVAD) system

Date:6/30/2022
Official Message No.:111394-6-30-2022-RECL
Contact Info: Eric | eric.lieberman@doh.nj.gov
William | william.manley@doh.nj.gov
Attachments: No

The FDA is providing updates to the FDA website to include information on recent recalls conducted by Medtronic. These recalls include information on battery performance issues as well as the availability of a modified software for select patients.

The FDA remains committed to providing updates about the safety profile of the HeartWare Ventricular Assist Device (HVAD) System.

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