MEDTRONIC HeartWare Ventricular Assist Device (HVAD) Class I Recall!

Have you been injured by a Medtronic HeartWare Ventricular Assist Device? The Medtronic HeartWare Ventricular Assist Device is designed to is a device that helps pump blood from the lower chambers of your heart (ventricles) to the rest of your body. It is used in people with end stage heart failure and are waiting for a heart transplant.

On June 8, 2022, the U.S. FDA announced a Class I recall¹ by Medtronic of its HVAD devices following complaints of patients experiencing “pump thrombosis”.²

Medtronic is recalling the HVAD Pump Implant Kit because of a pump weld defect, which has led to cases where moisture is able to enter the pump and cause the internal magnets in the device to corrode and demagnetize.³

The Medtronic recall affects over 1,600 devices distributed between October 11, 2006 and June 3, 2021. The product name is the “HVAD Pump Implant Kit”. The affected model numbers are 1101, 1103, 1104, 1104JP, and MCS1705PU.⁴

The defective Medtronic HeartWare Ventricular Assist Device have potentially caused “pump thrombosis.” This is a severe complication that can cause a pump to malfunction and is sometimes associated with blood clotting.

The law firm of Randall & Schumacher, P.A. is currently investigating cases where a Medtronic HeartWare Ventricular Assist Device may have been defective and caused a patient to need a device replacement and/or caused physical injury such as a blood clot (also known as a blood thrombosis), stroke, or death.

If your device has made abnormal pump sounds such as grinding sounds or pump alarms, showed excessive power spikes, or if you have felt light-headed or dizzy, your device may be subject to the recall!

Call Randall & Schumacher, P.A. at 833-515-6101 or contact us online to schedule a free consultation at our Minneapolis office.

 

1.  A Class I recall is the most serious type of recall under FDA regulations and involve risk of serious injury or death.
2. https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-hvad-pump-implant-kit-pump-weld-defect
3. https://www.acc.org/Latest-in-Cardiology/Articles/2022/06/08/20/28/FDA-Update-Agency-Announces-Recall-of-Medtronic-HVAD-Pump-Implant-Kit-For-Pump-Weld-Defect#:~:text=The%20U.S.%20Food%20and%20Drug,%E2%80%9Cserious%20injury%20or%20death.%E2%80%9
4. Another problem appears for Medtronic’s HeartWare device. By Burl Gilyard (https://www.startribune.com/burl-gilyard/8532056/. Star Tribune, April 28, 2022.