The U.S. Food and Drug Administration (FDA) announced that Medtronic has recalled its Pipeline Vantage 027 embolization device used to treat brain aneurysms, with 13 injuries and four deaths reported related to it.
The recall is due to reports of a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to blood vessel walls during and after procedures, according to a March 18 recall notice. The FDA identified the recall as Class I, the most serious type.
On January 30, 2025, Medtronic Neurovascular sent all affected customers an urgent medical device recall letter asking them not to use the device and to remove and quarantine all unused products.
In addition, the FDA said that MedTronic has issued updated instructions for use for its Pipeline Vantage 021 model, with four injuries reported related to the device. Revisions include optimized techniques for deploying the device, especially in patients with complex anatomy, and a warning on increased risk in females.
Both devices are used to treat brain aneurysms. They are inserted into blood vessels through a small catheter and delivered to the aneurysm location, where a small, braided tube is placed to block off blood flow to the area.