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# Medtronic Unit Recalls Brain Aneurysm Stents
- URL: https://www.fdaweb.com/medtronic-unit-recalls-brain-aneurysm-stents/
- Published: 2021-09-20T12:00:00.000Z
- Updated: 2026-09-14T17:15:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150179

Medtronic’s Micro Therapeutics unit (dba ev3 Neurovascular) has begun a Class 1 recall of its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology due to the risk that its delivery system wire and tubes could fracture and break off inside a patient. Attempts to retrieve the fractured pieces may make a patient’s condition worse, and fragments left in the bloodstream can cause other serious adverse health consequences such as continued blockage of blood vessels, stroke, and death, a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-pipeline-flex-embolization-devices-risk-delivery-system-fractures-during-placement?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. FDA says there have been 59 reported device malfunctions, 10 serious injuries, and two deaths related to this issue. The devices are permanent mesh stents intended for treating brain aneurysms that bulge or balloon out the sides of the blood vessel (wide-neck and fusiform).