Recalls for Ventricular Assist System Controllers

Heartware International Recalls Certain Older Heartware Clinical Trial Controllers
02/27/2015 Food Recall

HeartWare International, Inc. (Nasdaq: HTWR), is issuing a voluntary Urgent Medical Device Recall in the United States related to older HeartWare Ventricular Assist System Controllers, which were distributed in the U.S. during the clinical trial period prior to Food and Drug Administration (FDA) approval in 2012. HeartWare has commenced this field action in other countries in recent weeks.

  • Company:
    HeartWare
  • Problem
    Controllers exhibit a higher susceptibility to electrostatic discharge than newer, commercial controllers.