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Tuesday, June 28, 2022

Another FDA recall for Medtronic’s HeartWare device

The U.S. Food and Drug Administration issued another Class 1 recall for Medtronic’s HeartWare Ventricular Assist Device (HVAD) on Thursday, this time over the risk of battery failure.

Medtronic said it is replacing the affected batteries.

The news comes just two weeks after regulators issued a Class 1 recall for a different problem with the HeartWare device. Medtronic discontinued sales of the product in June 2021 after a series of problems surfaced. The FDA issues Class 1 recalls in cases where “use of these devices may cause serious injuries or death.”

“Medtronic is investigating a potential welding defect affecting a specific lot of external batteries for the HeartWare Ventricular Assist Device (HVAD) pump. The issue was initially identified through complaints that the battery has stopped providing power or failed to hold a charge,” said Erika Winkels, a Medtronic spokeswoman, in a statement.

According to the FDA, this welding defect could cause a battery malfunction and possible sudden failure. The latest recall affects 429 devices in the U.S., all manufactured during a single week in April 2021.

“Medtronic reports one death associated with this recall, and two complaints in the affected lot,” according to the FDA’s notice.

Medtronic issued an alert on May 5 to all patients potentially affected by the battery issue.

“We have communicated the potential for this device malfunction to all healthcare providers with patients who may have impacted batteries. We are retrieving the affected lot of batteries and replacing them,” Winkels said.

Madris Kinard, an expert in medical technology regulations and recalls, said the ongoing HeartWare recalls are troubling.

“There are other devices I’ve seen get recalled very quickly,” Kinard, CEO of Pennsylvania-based Device Events LLC, said. “Why this continues to be an issue is definitely a concern.”

Kinard’s company makes software that sifts through and analyzes FDA information on adverse events for medical devices. Her clients include health care organizations and insurance companies.

The recall earlier this month, which affected more than 1,600 devices in the U.S., was also due to a welding defect that could cause the pump to rotate incorrectly. The malfunction resulted in patients developing symptoms akin to pump thrombosis, which is a blockage in the flow of blood through a vessel.

Before that recall, about 3,800 patients still had implanted HVAD pumps.

The FDA’s notice two weeks ago said, “Physicians should make decisions about removing or exchanging the pump on a case-by-case basis, considering the patient’s clinical condition and surgical risks.”

The HVAD device was tailored to patients with severe heart failure; its mechanical pump was designed to increase blood flow through the body.

When it stopped selling the product last year, Medtronic reported receiving more than 100 complaints for the delay or failure to restart the pump. The problem was blamed for 14 deaths.

Medtronic was not the original developer of HeartWare. It acquired Massachusetts-based HeartWare International in 2016 for $1.1 billion.

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