Recall of Medtronic embolization devices classified as most serious by USFDA

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2025-03-20T16:45:00+05:30 | Updated On 20 March 2025 4:45 PM IST

Medtronic's recall of embolization device has been classified most serious by the U.S. Food and Drug Administration (USFDA), citing potential risks of severe injury or death. This decision follows the reports of four patient fatalities.

As per the USFDA, the affected product could lead to risk of severe adverse health consequences, including thrombosis, stroke, or death.

Thirteen injuries have been reported in connection with the use of the devices known as Pipeline Vantage Embolization devices.

The recall impacts the Pipeline Vantage devices compatible only with 0.027" inner diameter microcatheters, Medtronic said. The company added that it has taken the necessary steps to retrieve the recalled products and has notified regulatory agencies globally as appropriate.

The devices in question are used to treat bulges in the artery walls, or aneurysms, of the brain.

They are inserted into the blood vessels via a small catheter and delivered to the aneurysm site, where a small, braided tube is placed to obstruct blood flow to the bulging area.

The recall involves the withdrawal of the device models from all locations where they are currently in use or for sale, Reuters reported.

Medtronic is recalling the devices following reports of a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall during and after procedures involving these devices.

Incomplete wall apposition and braid deformation, also sometimes called fish-mouthing, braid narrowing, or braid collapse, are known risks of these devices, the regulator said, adding that the risks were higher in females, especially those younger than 45 years of age.

Read also: Medtronic receives USFDA clearance for new InPen app featuring missed meal dose detection

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Source : with inputs

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751