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.
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