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.
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