3 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.