Blood pump pulled from market after deaths and recalls

| Jul 7, 2021 | Defective Medical Device Litigation |

Medical technology led to the development of many devices that have prolonged life and reduced the severity of serious medical conditions. If these devices have defects, however, the results may be fatal and constitute grounds for a medical products liability lawsuit. In one case, Medtronic withdrew a HVAD pump system from the market in June that it acquired from another manufacturer after patient deaths and Food and Drug Administration recalls.

HVAD pump system

The HVAD pump is used to help heart patients pump blood through their bodies. It includes an implantable pump and other non-implantable components. The pump is an FDA Class III medical device which designates it as a high-risk device that can present a high risk of injury.

Medtronic acquired the HVAD pump when it acquired HeartWare International in 2016.

Malfunctions

The FDA issued 13 Class I recalls of the HeartWare system involving multiple parts and components. Malfunctions included over 100 cases of failure to restart. Other issues also involved the need for update use instructions and patient manuals.

Reports revealed 14 fatalities and 91 injuries related to issues with the device. The FDA advised practitioners in June to stop new implants of this system. It also cited 13 cases where an explant was necessary.

Some recalls were issued before Medtronic’s acquisition. Nine class I recalls, however, were issued since Medtronic acquired HeartWare. There were three class I recalls in 2021.

Thousands of reports of patient injuries, deaths and device malfunctions involving the HeartWare system were submitted to the FDA’s Manufacturer and User Facility Device Experience database. An analysis of MAUDE data for this device indicated that it had a higher rate of malfunction than comparable devices like Abbott’s Heartmate II Left Ventricular Assist System and HeartMate 3, according to the watchdog group ECRI.

Reported malfunction rates in MAUDE fell since Medtronic purchased HeartWare. MAUDE has limitations because reports can be inaccurate, duplicate or underreport fatalities and injuries.

Medtronic’s announcement

In its statement, Medtronic stated that it stopped the distribution and sale of its HVAD system. It acknowledged cited ongoing failures with the device, such as the delay or failure to restart and an increasing amount of observational clinical comparisons showing a higher frequency of strokes, other neurological adverse events and fatalities compared to other available circulatory devices.

Medtronic established a program to support approximately 4,000 patients who have this device implanted and is working with rival Abbott Laboratories to ensure that patients have access to alternative devices. Abbott said that it has sufficient capacity supporting the demand for these devices.

Attorneys can help gather evidence of defects. They can pursue the right to compensation in court and negotiations.