FDA announces recall of Medtronic interventional radiology devices after 17 injuries, 4 deaths
The U.S. Food and Drug Administration (FDA) has announced that Medtronic Neurovascular is recalling two different models of its Pipeline Vantage Embolization Devices with Shield Technology due to ongoing safety concerns.
The Pipeline Vantage 027 device was linked to 13 injuries and four reported deaths and is being completely removed from the market.
The Pipeline Vantage 021 device, meanwhile, was linked to four reported injuries. It is not being removed from the market, but its instructions for use have been updated to highlight certain risks.
Interventional radiologists use these devices when treating brain aneurysms. They are inserted into a patient’s blood vessels through a small catheter to block off blood flow.
What caused the medical device recall?
The problems at the center of this recall involves the flexible, braided tube part of the devices failing to stay attached to the blood vessel wall during and after embolization procedures.
“Incomplete wall apposition and braid deformation, also sometimes called fish-mouthing, braid narrowing, or braid collapse, are known risks of these devices,” according to the advisory. “The risks were higher in females, especially those younger than 45 years of age. The use of affected product may cause serious adverse health consequences, including thrombosis, stroke or death.”
Physicians who have already treated patients with these devices are advised to “determine the need for follow-up imaging or changes to medical management based on the patient’s overall health.”
The updated instructions for the Pipeline Vantage 021 device are available online.
Click here to read the full advisory.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.