The FDA has announced that Medtronic is recalling nearly 9,000 Pipeline Flex embolization devices due to the risk of serious malfunctions.
This is a Class I recall, which means the issue can lead to serious injury or death. It has been associated with 59 malfunctions, including two deaths and 10 serious injuries.
The malfunctions have been seen in Pipeline Flex embolization devices with and without shield technology. They occur when the devices, designed to treat wide-necked intracranial aneurysms, are being used to “place, retrieve or move the stent inside a patient.”
“Fractured pieces could be left inside the patient’s brain bloodstream,” according to the FDA. “It is also possible that attempts to retrieve the fractured pieces may make the patient’s condition worse. The fragments can also cause other serious adverse health consequences such as continued blockage of blood vessels, stroke and death.”
The devices included in this recall were all distributed from April 18, 2019, to August 13, 2020. Healthcare professionals are advised to stop using these products and immediately quarantine them. They should then be returned to Medtronic.
For a full list of affected product codes, and additional information from the FDA, click here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.