HeartWare recalls HVAD pumps due to potential severe health consequences
HeartWare recalled some of its HVAD ventricular assist device pumps due to a design problem that could cause serious adverse events, including death.
The FDA classified the action as a class I recall, which means there is a reasonable probability that using or being exposed to the device will cause serious adverse health consequences or death.
In the United States, 105 units have been recalled. The recall affects HVADs with serial numbers lower than HW25838 and product codes 1103 and 1104. The devices were manufactured from March 17, 2006, to June 27, 2016.
The issue arose with problems with the HVAD’s driveline connector, which connects the pump to the external controller and power source, according to an FDA news release. If the driveline is contaminated, material could enter the pump and cause electrical issues that could lead to death and other severe adverse health consequences.
The HVAD is used in patients who are at risk of death from end-stage left ventricular heart failure and waiting for a heart transplant.
This is the latest issue with the HVAD. In late September, Medtronic acknowledged that the FDA had classified two actions as class I recalls. Two days before Medtronic agreed to acquire HeartWare in late June, the FDA said HeartWare voluntarily recalled batteries for the HVAD system because the batteries could lose power due to faulty cells. Medtronic acquired HeartWare in August for approximately $1.1 billion.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.