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.