Recalls for HeartWare

HeartWare Ventricular Assist System: Class I Recall - Damaged Alignment Guides or Connection Pins May Cause Pump to Stop
06/16/2015 Medical Recall

An interruption in electrical connection would cause the pump to stop, which could cause serious patient injury or death.

  • Company:
    HeartWare
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.