This Class I recall, linked to two patient deaths, is the third in 12 months for Medtronic’s HeartWare HVAD ventricular assist device, reports MedTech Dive.
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.
Read more at MedTech Dive.
