25 results

• Heartware Ventricular Assist Device Recall Issued Due to Loose Connector Risk

  October 31, 2016

  Irvin Jackson

  Another HVAD recall has been announced, this time involving heart pump controllers that may have loose connections.

• Heartware Ventricular Assist Device Recall: Electrical Problems That Could Cause Death

  October 24, 2016

  Martha Garcia

  A risk of malfunctions that could cause serious injury or death has led to the recall of some Heartware Ventricular Assist Device heart pumps.

• HeartMate II, HeartWare LVAD Devices Linked to Reports of Serious Problems , FDA Warns

  August 6, 2015

  Irvin Jackson

  The FDA is warning of serious adverse event risks tied to two heart implants, the HeartMate II and the Heartware HVAD, which could cause bleeding, strokes, and blood clot problems.

• HeartWare Ventricular Assist System Recall: Bent Pins Could Lead To Death

  June 17, 2015

  Russell Maas

  HeartWare is recalling hundreds of ventricular assist systems because connector pins can become bent, creating a risk of serious injury or death for patients.

• HeartWare VAD Problems May Have Caused Serious Injuries, Deaths: FDA

  July 14, 2014

  Irvin Jackson

  The FDA has issued a warning letter to HeartWare, which indicates that it failed to make sure that corrections to a problem with the HVAD controller, already linked to at least four serious injuries and two deaths, was properly addressed.