14 results

• Thoratec HeartMate System Monitor Recall Issued Due Screen Problems That May Lead to Brain Damage, Strokes, Death

  July 2, 2024

  Irvin Jackson

  The FDA has announced a Class I recall for Thoratec HeartMate System Monitors, due to screen issues that have been linked to more than a dozen patient injuries; the latest in a long line of the left ventricular assist system recalls.

• Abbott Heartmate 3 Recall Issued After Reports of Blood Leaks, Air Embolism and Heart Failures

  May 16, 2024

  Russell Maas

  The FDA has issued another Heartmate 3 LVAD recall, one of several in recent months, due to air and blood leaks that have been linked to at least eight patient deaths.

• HeartMate II and HeartMate 3 LVAS Recall Follows 14 Deaths, Hundreds of Injuries

  April 16, 2024

  Russell Maas

  Nearly 14,000 Heart HeartMate II and HeartMate 3 LVAS devices are being recalled due to the risk of potentially lethal blockages that have already led to more than a dozen deaths.

• Heartmate II LVAS Pocket Control Recall Issued Following Deaths, Malfunctions

  May 25, 2017

  Irvin Jackson

  About 29,000 HeartMate II LVAS pocket controllers are subject of an FDA recall warning following the death of 26 patients who tried changing the controller improperly or too slowly.

• 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.

• Left Ventricular Assist Devices (LVADs) Linked to Risk of Cognitive Problems: Study

  May 4, 2015

  Irvin Jackson

  A new study suggests that heart implants like the HeartMate II may cause a decline in mental functioning and memory in older patients.

• Thoratec HeartMate II Pocket Controller Recall Issued After Deaths

  April 2, 2014

  Irvin Jackson

  The FDA says that a Thoratec warning regarding the pocket controller for its HeartMate II LVAS should be considered a class I recall following reports of deaths and serious injuries.

• Thoratec HeartMate II Complications Linked to Pre-Operative Risks

  March 26, 2014

  Irvin Jackson

  A new study highlights how some risk factors may affect whether individuals experience complications with Thoratec HeartMate II performance.

• Thoratec HeartMate II Pocket Controllers Linked to Four Deaths

  March 5, 2014

  Irvin Jackson

  Thoratec announced that four patients had died trying to switch controllers for a new HeartMate II LVAS Pocket Controller, and advised patients to get updated training on the new models.

• Thoratec HeartMate Class Action Lawsuit Filed by Investors

  January 28, 2014

  Irvin Jackson

  A new class action lawsuit claims Thoratec lied to investors about the safety of its HeartMate II implants.