A new report indicates the FDA and Medtronic knew of HeartWare implant problems and deaths for years, but took little action to make the devices safer and kept allowing them…
The FDA warns that a heart pump used for emergency procedures has a high rate of death among some types of patients.
A Class 1 medical device recall has been issued for Abiomed, Inc.’s AB5000 Circulatory Support System after it was determined that the device, which keeps the heart pumping in cases…
Thoratec Corporation has warned that their HeartMate II blood pump may fail due to a defective lead that connects the heart pump with the System Controller. The lead has been…