The U.S. Food and Drug Administration on Tuesday announced a Class 1 recall — the most serious level — affecting more than 26,000 Medtronic devices used to treat brain aneurysms. The recall comes after four reported deaths and 17 injuries.
The recall affects two versions of the device. For its Pipeline Vantage 021 models, Medtronic is updating the instructions for use. And for the Pipeline Vantage 027 model, the company is asking doctors to return them, the agency said.
The recall doesn’t ask doctors to remove the device from patients who have it implanted.
The devices block off blood flow to the bulging area of the aneurysm, the FDA said. The model numbers 021 and 027 refer to the size of microcatheters used to insert the device, shaped like a small braided tube, into the brain.
The Fridley-run company has received a higher-than-expected incidence of these Pipeline Vantage products failing to properly attach or stay attached to blood vessel walls during and after procedures, the FDA said. The risks were higher in females under 45 years old.
A Medtronic spokesperson wrote in an email, “Safety and well-being of our patients and customers is our top priority.”
“We have worked in close collaboration with the United States Food and Drug Administration (FDA) and other international regulatory bodies during this process,” the spokesperson said. ”We have taken the necessary steps to retrieve the recalled products and notified regulatory agencies globally as appropriate."
The spokesperson said the recall, affecting 18,245 of the 027 devices and 7,820 of the 021 devices, occurred after the company performed an investigation and analysis. The 027 device is linked to 13 reported injuries and four reported deaths, while the 021 device is linked to four reported injuries and no reports of death, the FDA said.
