UPDATE: June 14, 2022: Medtronic has received “no new and confirmed reports of injuries, death or malfunctions associated with the potential pump weld matter” following letters sent to physicians and healthcare providers in April warning of potential device malfunctions with the HeartWare Ventricular Assist Device (HVAD) System.

A spokesperson wrote in an emailed statement that Medtronic will continue to submit reports to the Food and Drug Administration in accordance with regulatory requirements.

Medtronic is “committed to ongoing quality assessments and control measures to further patient safety and therapy effectiveness. Medtronic has notified, and is working with, all applicable regulatory agencies and authorities on this matter,” the spokesperson said.

On April 11 and April 26, the company sent letters to healthcare providers warning them of potential patient harm from a device defect and asked that devices be returned. The FDA then published a letter to healthcare providers on April 28 regarding the safety issues.

While the FDA’s notice from last week said the recall was initiated on April 11, the agency did not reference the recall in its April 28 published letter.

The FDA was aware of Medtronic’s letters when the agency published the letter to providers on April 28, an FDA spokesperson wrote in an emailed statement. The spokesperson added that the FDA considered Medtronic’s letters as phase 1 and phase 2 of the recall, and it subsequently classified the actions as a Class I recall on June 3.

The Medtronic spokesperson noted that when the company pulled the devices from the market in June 2021, it “advised clinicians to cease all pump implants and return unused product to the company.”

There are approximately 3,500 patients who have the HVAD device implanted, according to the company. When the device was pulled from the market in June 2021, approximately 4,000 patients had the device implanted.

“In consultation with our Independent Practitioner Quality Panel, composed of cardiologists, surgeons and VAD coordinators, routine prophylactic explant of HVAD devices is not recommended, as risks associated with explantation may outweigh the potential benefits,” the spokesperson said in an emailed statement.

Dive Brief:

• Medtronic’s latest recall for the HeartWare Ventricular Assist Device (HVAD) System has been labeled by the Food and Drug Administration as a Class I event following reports of patient injuries and one death.
• The company is recalling HVAD pump implant kits due to a welding defect in certain devices that could allow moisture to enter and cause the corrosion and demagnetization of internal magnets, which can cause the pumps to rotate incorrectly, according to the FDA’s notice on Wednesday. The agency said that patients with affected devices may show signs and symptoms resembling a blocked pump. If the issue occurs, it can lead to “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,” the FDA said.
• Medtronic has received three complaints regarding the issue, including one patient death and two injuries, according to the regulator. The recall was initiated on April 11 and affects 1,614 devices in the U.S.

Dive Insight:

The HVAD System has a history of more than a dozen recalls and thousands of reports of patient injuries and deaths. An analysis of FDA data by ECRI and provided to MedTech Dive also showed that the device had a higher rate of malfunctions than rival devices from Abbott Laboratories.

The device, which helps patients with heart failure pump blood throughout their bodies, was ultimately pulled from the market last June. At the time, Medtronic said that the decision was due to “a growing body of observational clinical comparisons indicating a higher frequency of neurological adverse events, including stroke, and mortality with the HVAD System as compared to other circulatory support devices available to patients.”

The ongoing issues with the HVAD System caught the attention of Rep. Raja Krishnamoorthi, D-Ill., who sent a letter to the FDA in March asking for clarity about the regulatory history of the device. The representative wrote that the agency, over multiple administrations, had “failed to protect consumers from the dangerous HVAD System.”

Medtronic’s latest recall comes after the company and the FDA warned providers of the pump weld defect in April. In a letter to providers, the company said that it was investigating three devices that were returned and suggested a welding defect that allowed moisture to get into the device and disrupted the internal pump’s correct rotation.

Medtronic said that all three of those patients had pump exchanges and two patients died following the exchanges.

On April 28, the FDA published a letter to providers regarding the potential for pump malfunctions due to possible welding defects but did not mention a recall. According to the FDA’s Thursday notice, the recall was initiated by the company on April 11.

Medtronic sent a letter on April 11 to select providers and physicians that had unused pump implant kits and asked for the products to be returned, according to the FDA. Then on April 26, the company sent a letter to all physicians and providers to inform them of the potential defect.

In a letter to customers, Medtronic said that physicians should make decisions about removing or exchanging pumps “on a case-by-case basis, considering the patient's clinical condition and surgical risks,” according to the FDA’s notice on Thursday.

The Medtronic recall follows other product safety issues at the company over the past two years. The FDA has posted six Class I recall notices for Medtronic in 2022, including one for its subsidiary Covidien. Last year, the agency posted 10 Class I notices, including the notice that Medtronic was stopping the sales and distribution of the HVAD System.

CEO Geoff Martha addressed the recalls at J.P. Morgan’s annual healthcare conference in January. Martha said that the problems would become his “top priority” and the company was “increasing accountability and aggressively accelerating plans to enhance patient safety and improve our quality performance.”