FDA has classified another recall of Medtronic's HeartWare HVAD ventricular assist device as a Class I event in light of the potential for serious harm.
Medtronic is recalling 157 HVAD Pump Implant Kits from the U.S. after receiving complaints that some devices have failed to start or restart promptly. Two deaths have been linked to the fault.
FDA has now issued three Class I recalls related to HeartWare in the past 12 months. Last year, reports of five deaths linked to faults with the devices led to two Class I recalls.
The nature of HeartWare means any problems with the device can have severe consequences. Users of HeartWare with conditions such as end-stage heart failure rely on the pump to help their left ventricles get blood around the body. The system consists of an implantable pump and an external controller.
Medtronic is recalling the pump implant component of HeartWare in light of 29 complaints about the products. Some kits have failed to start or restart. Other kits have only restarted after a delay.
Some users detected the faults during pre-implant testing. However, other devices that later proved to have the fault were implanted. The failure of the device to start or restart promptly could lead to harms including heart attacks, additional procedures and hospitalizations, as well as worsening heart failure and deaths, FDA said
FDA is aware of reports of 19 serious injuries and 8 cases of patients who had a "life-threatening event but recovered without long term effects." Two patients have died.
The agency reiterated the advice Medtronic shared in its notice to healthcare professionals late last year. Medtronic recommended keeping the controller connected to the driveline and at least one power source. Physicians should take precautions when exchanging controllers due to the risk that the pump will fail to restart.
News of the Class I event follows two recalls of HeartWare products last year. In March 2020, FDA issued a Class I recall notice about the potential for users to insert the battery charger adapter into the wrong port. One death was linked to the issue. In May, FDA issued a separate Class I recall notice about an outflow graft problem linked to four deaths.
Medtronic initiated the latest recall in November 2020 and sent an Urgent Medical Device Communication Letter to all affected customers in December, according to FDA.