Benzinga | Sep 20, 2021 02:59PM EDT

Medtronic Recalls Pipeline Flex Embolization: What You Need To Know

* Medtronic Plc (NYSE:MDT) is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology stents due to a risk of the devices' wires and tubes fracturing and breaking off.

* The devices are used for brain aneurysms that bulge or balloon out the sides of the blood vessel (wide-neck and fusiform).

* The Pipeline Flex Devices include a guidewire-based delivery system used to place the implant inside the patient.

* The FDA says that fractured pieces could be left inside the patient's brain bloodstream.

* The agency also noted that the attempts to retrieve the fractured pieces might worsen the patient's condition.

* The fragments can also cause other serious adverse health consequences such as continued blockage of blood vessels, stroke, and death.

* So far, the FDA says there have been 59 device malfunctions reported, ten serious injuries, and two deaths related to the products.

* The agency had classified the recall as Class I, the most serious type of recall.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: MDT stock is down 1.56% at $127.69 during the market session on the last check Monday.