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FDA & Government News

Medtronic Recall: FDA Issues Highest-Risk Warning

The FDA has classified the recall of Medtronic’s Pipeline Vantage embolization devices as its most serious, citing risks of thrombosis, stroke, and death. The devices, used to treat brain aneurysms, have been linked to multiple patient injuries and fatalities.

Reuters
The FDA classified the recall of Medtronic's Pipeline Vantage embolization device as its most serious, citing risks of thrombosis, stroke, and death following reports of four patient fatalities.

The recall applies to Pipeline Vantage devices compatible with 0.027" inner diameter microcatheters, Medtronic said. The company stated it has taken steps to retrieve affected products and has notified regulatory agencies globally.

The devices are used to treat intracranial aneurysms by diverting blood flow away from the aneurysm sac. They are deployed via a catheter into the blood vessel, where a small, braided tube is positioned to promote vascular remodeling.

Medtronic initiated the recall after reports of an increased incidence of incomplete wall apposition and braid deformation, including fish-mouthing, braid narrowing, or collapse. These structural failures may prevent proper vessel wall adherence during and after deployment.

Thirteen injuries have been reported in association with these devices. The FDA noted that the risk of these complications appears higher in female patients, particularly those under 45 years of age.