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# Medtronic Recalls Vantage Embolization Devices
- URL: https://www.fdaweb.com/medtronic-recalls-vantage-embolization-devices/
- Published: 2025-03-18T12:00:00.000Z
- Updated: 2026-09-14T14:55:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158848

Medtronic Neurovascular is recalling its Compatible Pipeline Vantage Embolization (027) Devices and updating the use instructions for their 021 version due to reports about the flexible, braided tube part of the device failing to properly attach or stay attached to blood vessel walls (incomplete wall apposition or braid deformation) during and after procedures using these devices. “Incomplete wall apposition and braid deformation, also sometimes called fish-mouthing, braid narrowing, or braid collapse, are known risks of these devices,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/embolization-device-recall-and-correction-medtronic-removes-unused-027-compatible-pipeline-vantage?ref=fdaweb.com) says. The risks were higher in females, particularly those under the age of 45 years.

The use of affected product may cause serious health consequences, including thrombosis, stroke, or death, the notice says. To date, there have been 13 reported injuries and four reports of death related to the 027 embolization device, and there have been four reported injuries and no reports of death related to the 021 embolization device.

The devices are intended for use in treating bulges (aneurysms) in the brain’s artery walls. They are inserted into the 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 bulging area, the company says.