3 results

• 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.

• SynCardia Heart Transplant Devices Linked To High Mortality Rate, Malfunctions, FDA Warns

  October 27, 2016

  Irvin Jackson

  Two devices used to assist heart transplant patients have been linked to an increased risk of strokes, mortality and life-threatening malfunctions, according to a new warning by the FDA.