HeartWare Recalls 120 Heart Pump Controllers
About the HeartWare VAD Controller Recall
The recall is for controllers that were distributed before the VAD's 2012 FDA approval as a bridge therapy for patients awaiting heart transplantation.
The recall states that an issue with the constrollers can cause an electrostatic discharge, which leads to malfunction and can cause the VAD to stop working.
Previously, in 2013, HeartWare issued a Field Safety Correction Action because of electrostatic concerns. The issue was linked to serious injuries and at least one death.
HeartWare was cited by the FDA in 2014 for failing to take appropriate measures to respond to 27 complaints of controller failure that were received over a three-year period.
Models Affected by the Recall
The products affected by the recall have codes 1400 and 1401XX, which were distributed during the company’s ADVANCE and ENDURANCE clinical trials.
The recall affects approximately 120 U.S patients.
Class 1 recalls are reserved for product defects that may result in serious injury and death.