Medtronic’s Recalled HVAD Pump Implant Kit Killed One, Injured Two, FDA Says

The FDA issued an update on Medtronic’s April 11 recall of its HeartWare Ventricular Assist Device (HVAD) pump implant kit, deeming it a Class 1 recall because of the risk of serious injury or death.

One patient death and two injuries were reported in connection with the recalled kit, the agency said.

An analysis of pumps returned to Medtronic showed that a weld defect had allowed moisture that entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which “may cause the pump to rotate incorrectly,” the FDA said.

If the pump malfunctions, it could lead to organ dysfunction, a stroke or death, or it may require patients to undergo major surgery to replace the pump, the agency said.

The 1,614 affected products, model numbers 1101, 1103, 1104, 1104JP and MCS1705PU, were distributed from Oct. 11, 2006 to June 3, 2021.