Medtronic recalls brain stent after 10 injuries, 1 death

Medtronic is recalling 822 of its pipeline flex embolization devices, which are used to treat brain aneurysms, after finding the delivery system can break during surgery and leave fractured pieces inside patients' brain bloodstreams. 

The device is a permanent mesh cylinder intended to be placed inside a patient's brain to treat an aneurysm. The delivery system used to place the cylinder in a patients' brain was found to have a risk of fracturing during surgery. 

If the device fractures, the fractured pieces or attempts to remove them could cause serious adverse effects, such as blocked blood vessels, stroke and death.

Medtronic has received reports of 10 injuries and one death stemming from the recalled devices that took place between November 2019 and March 2020. 

If the device has already been successfully implanted, there's no increased risk to patients due to the issue causing the recall, Medtronic said. 

Medtronic told its customers to remove and quarantine all the recalled devices from their inventories and return them to Medtronic. 

Read the full news release here.

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