Medtronic Recalls Embolization Devices Linked to Injuries and Deaths

Medtronic has issued a recall of certain embolization devices following reports of 17 injuries and four deaths, according to the U.S. Food and Drug Administration (FDA).

The recall includes two actions: removing Pipeline Vantage 027 devices from the market and updating usage instructions for Pipeline Vantage 021 devices.

The Pipeline Vantage 027 devices are associated with the most reported injuries and all four deaths.

The recall follows reports that the flexible, braided tube component of these devices may fail to properly attach or stay in place on the blood vessel wall during and after procedures, increasing the risk of thrombosis, stroke, and death. The FDA states that Pipeline Vantage 027 devices have been linked to 13 injuries and four fatalities.

According to a Health Canada notice, as of late 2024, Medtronic had received 416 complaints related to approximately 18,200 Pipeline Vantage 027 units distributed worldwide. The agency noted that these devices appear to have a higher incidence of stent braid deformation compared to other models, typically occurring six to twelve months post-procedure. The risk is higher in women under 45.

Medtronic and the FDA are instructing healthcare providers to discontinue using all affected Pipeline Vantage 027 devices and remove and quarantine any unused units.

The Pipeline Vantage 021 devices remain on the market, with Medtronic updating its instructions for use. The FDA reports four injuries and no deaths linked to these devices. Health Canada has recorded four stroke cases and 57 complaints among 7,400 distributed units.

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