The FDA classified two recalls of the HeartWare ventricular assist device (HVAD) system as class I recalls.
The agency defines a class I recall as meaning there is reasonable probability that using or being exposed to the device will cause serious adverse health consequences or death.
The HVAD system includes a ventricular assist device and controller that monitors the pump. It is intended for patients with advanced heart failure as they await heart transplantation.
HeartWare sent a safety notification letter in May and June notifying physicians to inspect patients’ HVAD HeartWare controllers for loose connectors asking them to remind patients how to safely use the HVAD system, according to Medtronic.
The company said that approximately 8,799 HVAD HeartWare controllers could have been affected by the recall. As of Sept. 26, Medtronic had replaced 308 of the affected HVAD controllers. The company said that all clinician notifications in the U.S. and 99 percent of clinician notifications worldwide had been acknowledged.
“Damage to the controllers from this issue could cause loss of communication between the controller and monitor, reduced ability to detect alarms or interruption of circulatory support due to pump stop, which could lead to serious injury or death,” Medtronic said in a news release.
Medtronic also mentioned that HeartWare voluntarily recalled certain models of unimplanted, sterile HVAD pump implant kits in hospital inventory in August. The pumps could have been susceptible to electrical faults and connection failures, which could result in serious injury or death.
The company said 323 of the 350 potentially affected implant kits had been used or returned to HeartWare as of Sept. 26. In addition, all clinician notifications in the U.S. and 89 percent of clinician notifications worldwide had been acknowledged.
HeartWare has had previous issues with its HVAD system, as well. On June 29, two days before Medtronic agreed to acquire HeartWare, the FDA said HeartWare voluntarily recalled batteries for the HVAD system because the batteries could lose power due to faulty cells.