Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk the delivery system could fracture while placing the stent inside the patient. The U.S. FDA has identified this as a Class 1 recall—the most serious type.
Fractured pieces of the delivery system could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces, can make the patient’s condition worse. This can also cause other serious adverse health consequences such as continued blockage of blood vessels, stroke, and death. If a Pipeline Flex Embolization Device (the permanent flow diverting stent) has already been implanted successfully, there is no increased risk to patients due to this issue.
The FDA has received 50 Medical Device Reports, with 10 injuries and 1 death, from November 1, 2019 to March 1, 2020.
Read the full story on the FDA’s website.