17 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 Touch Communication System Recall Issued After Reports of Injuries

  March 12, 2024

  Hannah Brown

  The FDA has announced a recall of more than 1,500 HeartMate 3 Touch Communication Systems, indicating that problems with the device may lead to serious patient injuries or death.

• Medtronic HVAD Stroke Risk May Be Higher Than HeartMate3: Study

  August 19, 2021

  Irvin Jackson

  A new study reveals the recently recalled Medtronic Heartware HVAD system has more than double the risk of causing neurological adverse events in patients than the Abbott Heartmate3, which is still on the market, but plagued with problems of its own in recent years.

• Abbott Warns of New Problems With HeartMate 3 Systems

  December 12, 2019

  Russell Maas

  Abbott is warning of power loss problems with its HeartMate 3 implants, which could lead to serious injuries or even death.

• 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.