HVAD Problems Still Linger for Medtronic

Medtronic is still facing issues stemming from the HeartWare Ventricular Assist Device (HVAD) – even though the technology was pulled a year ago. FDA has hit the HVAD Pump Implant kit with a Class I recall, the most serious type of recall.

FDA said 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.

The agency said if this issue occurs, it could 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.

FDA noted Medtronic received three complaints regarding this device issue, including one death, and two injuries.

The recall is looking at 1,614 HVAD devices distributed from Oct. 11, 2006, to June 3, 2021.

The HVAD 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 has had a history of problems with HVAD devices. In 2015, HVAD made a list compiled by MD+DI titled, “10 Medtech Recalls that Shocked the Industry.”

The company inherited the HVAD device when it acquired HeartWare for about $1.1 billion.

Even when the acquisition was announced HeartWare was having issues with MVAD, its next-generation HVAD technology - noting the company halted a trial for the CE mark because it found certain algorithms, which appear to increase the potential" for blood clots in the pump.

However, there was a huge need for Medtronic to acquire HeartWare. At the time, St. Jude Medical had acquired HeartWare’s rival, Thoratec. (Editor’s Note: Abbott Laboratories went on to acquire St. Jude and inherit Thoratec’s LVAD device.)

When Medtronic said it was pulling HVAD off the market, Abbott Laboratories said it had the capacity and supply to effectively support the growing demand for mechanical circulatory support devices with its HeartMate 3 device.