IRELAND – FDA has hit Medtronic with a Class I recall for its HeartWare Ventricular Assist Device (HVAD) Pump Implant kit, the most serious type of recall.
Medtronic is still facing issues stemming from the HVAD – even though the technology was pulled a year ago.
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 HeartWare Ventricular Assist Devices (HVADs) distributed from October 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.
The devicemaker, which paid US$1.1 billion for the entire HeartWare company in 2016, decided to discontinue the HVAD system in June of last year.
The decision came after a decade of safety concerns and complaints about the device, which was designed to assist the heart in pumping blood to the rest of the body in patients with heart failure.
When Medtronic removed the heart pump from the market, it advised the approximately 4,000 people who had already been implanted with the device not to seek removal because the procedure could be more dangerous than any potential system defects.
Even when the acquisition was announced HeartWare was having issues with Muscle Powered Ventricular Assist Device (MVAD), its next-generation HeartWare Ventricular Assist Device (HVAD) technology.
Medtronic announced at the time that it 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.
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.
While the safety issue was first announced to patients and healthcare providers in an urgent medical device correction at the end of April, it has since been upgraded to a full-fledged recall, earning the FDA’s most serious Class I rating this week.
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