Medtronic has recalled its HeartWare Ventricular Assist Device (HVAD) System, which is designed to help the heart continue to pump blood to the rest of the body. The FDA identified it as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The HeartWare Ventricular Assist Device system is used as a bridge to cardiac transplants in patients who are at risk of death from end-stage left ventricular heart failure, for heart tissue recovery, or as destination therapy (DT) in patients for whom heart transplants are not planned.
Medtronic is recalling the HVAD Pump Implant Kit due to a pump weld defect. Following an inspection of explanted pumps returned to Medtronic, an analysis showed moisture had entered the center post of the pump causing corrosion and demagnetization of the internal magnets, which may cause the pump to rotate incorrectly. Patients with affected devices may present with signs and symptoms that resemble pump thrombosis.
If this issue occurs, it may lead to pump malfunction, death, or severe injury (for example: shock with severe organ dysfunction, stroke), or require patients to undergo major surgery to replace the pump.
Medtronic has received three complaints regarding this device issue, including one death, and two injuries.
The recalled product was distributed between Oct. 11, 2006 to June 3, 2021. Approximately 1,614 of the devices were recalled.
On April 11 2022, Medtronic sent an Urgent Medical Device Correction letter to select physicians and health care providers who have unused HVAD Pump Implant Kits to request that the product be returned.
Then on April 26, 2022, Medtronic sent an Urgent Medical Device Correction letter to all physicians and health care providers to inform them of this potential pump weld defect.
Featured image: The HeartWare Ventricular Assist Device System. Photo: FDA