HeartWare Receives FDA Warning Letter
The FDA is requiring that HeartWare take additional measures to address issues with their VAD, a medical device that has been linked to dozens of complaints and multiple deaths.
About the HeartWare VAD
The HeartWare Ventricular Assist Device (VAD) system was approved by the US Food and Drug Administration (FDA) in November 2012 as a bridge therapy for patients awaiting heart transplant.
Medscape reports that over a three-year period, HeartWare has received 27 complaints concerning the device linked to controller failure due to electrostatic discharge. This defect has been linked to four serious injuries and two deaths.
The FDA inspected a HeartWare manufacturing plant in January 2014, and they issued a letter stating that HeartWare did take corrective steps to deal with the failures related to the VAD.
However, the agency also noted that HeartWare had failed to verify the success of those measures and issued a second letter on June 2, 2014 to warn HeartWare about the violations and request that addition measures be taken.
Details of FDA Warning Letter
According to the letter:
- HeartWare failed to properly correct failures related to the electrostatic discharge and take effective action to address loose driveline connectors.
- HeartWare did not address the 238 complaints related to the battery failure following the FDA’s instructions to take “corrective and preventive action”
- HeartWare failed to record investigations for the VAD, take appropriate measures to prove the safety of the VAD’s design, and to validate the VAD’s computer software.
HeartWare was given 15 days to notify the FDA about the corrective measures to be taken and to provide explanations of how the steps will prevent similar violations from occurring in the future.