24 results

• HVAD Injury, Death Reports Long Before Recall Draw Questions from Congressional Oversight Subcommittee

  March 28, 2022

  Irvin Jackson

  A key U.S. lawmaker is asking the FDA to explain why it was slow to act on Medtronic HVAD system problems, despite receiving reports of patient injuries and deaths for years.

• Medtronic HeartWare HVAD Removed From The Market Following Recalls, Injuries and Deaths

  June 4, 2021

  Austin Kirk

  After issuing a series of Class I recalls for HeartWare HVAD systems over the past decade, Medtronic has announced that...

• Medtronic HeartWare HVAD Instruction Recall Issued Over Safety Concerns

  May 13, 2021

  Russell Maas

  Another Medtronic HeartWare HVAD recall has been issued, this time to clarify instructions which, if misinterpreted, could lead to serious injuries and deaths.

• Medtronic Heartware HVAD Cable Recall Latest Of Heart Device’s Woes

  April 16, 2021

  Russell Maas

  The latest in a series of Medtronic HeartWare HVAD recalls in recent years comes after at least 12 deaths and hundreds of complaints of problems with battery cables and data connectors.

• Medtronic HVAD Pump Recall Issued After Deaths, Life-Threatening Injuries Reported

  March 2, 2021

  Russell Maas

  A Medtronic HVAD pump kit recall comes after dozens of incidents and injuries and two deaths which occurred when power to the devices failed.

• Medtronic HeartWare HVAD Recall: Defective Screw Placing Patients At Risk Of Injury, Death

  May 29, 2020

  Russell Maas

  A Medtronic HeartWare HVAD implant recall warns that a defective screw could result in delay in treatment, bleeding injuries, and death.

• Air Pollution Decreases Risk Of Surviving Heart Transplant: Study

  December 16, 2019

  Martha Garcia

  A new study links air pollution exposure to a lower chance of surviving a heart transplant after five 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.

• FDA Warns Of High Mortality Rate with SynCardia Artificial Heart System

  August 20, 2018

  Russell Maas

  The FDA is warning that new drivers for the SynCardia System’s Temporary Total Artificial Heart (TAH-t) may increase the risk of death and strokes in patients.

• SynCardia Heart Transplant Devices Continue To Show High Mortality Rates, FDA Warns

  September 27, 2017

  Martha Garcia

  The FDA has released more data highlighting the mortality risks linked to a SynCardia heart transplant device linked to high death rates.