Medtronic Pipeline Flex Embolization Device Receives an FDA Class I Recall After Two Reported Deaths
The FDA has issued another Class I recall of Medtronic’s Pipeline Flex embolization device after receiving reports of 59 malfunctions, ten severe injuries, and two fatalities. Medtronic Pipeline Flex Embolization Device is used to treat brain aneurysms. Medtronic is recalling about 9,000 embolization devices in the United States due to a defect that can cause the delivery system’s tubes and wire to fracture once the stent has been implanted or retrieved. The fracture can “leave pieces in the patient’s brain bloodstream,” the FDA stated.
This expanded recall of Medtronic’s Pipeline Flex Embolization Device is only five months after the FDA approved Medtronic’s updated version of the device that incorporated a “new shield technology.” The update included a modification of the surface material used in the implant.
Medtronic introduced the Pipeline Flex Embolization Device ten years ago as a solution to correct intracranial aneurysms by redirecting blood flow. According to Medtronic, the Pipeline Flex Embolization Device has been extensively adopted as a remedy to stop rupturing of the aneurysm. Aneurysm ruptures kill about 500,000 people each year.
The FDA originally noted a fracture risk with Medtronic’s Pipeline Flex Embolization Device in March of 2020. At that time, only 822 of the devices were recalled. According to FDA, this recall includes several models of the Pipeline Flex Embolization Device with Shield Technology and the Pipeline Flex Embolization Device. Medtronic began the recall on July 13, and the recalled devices were distributed from April 18, 2019, until August 13, 2020.
Medtronic published one-year results from its SHIELD study, which demonstrated 77.2% occlusion (closure of a diseased blood vessel). The study stated that about 8% of those implanted with the recalled device sustained a severe adverse event.
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