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Medtronic & FDA Recalls Pipeline Flex Embolization Devices
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September 20, 2021 – San Diego, CA. Today the FDA has issued a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The Medtronic Pipeline™ Flex Embolization Device and Pipeline™ Flex Embolization Device with Shield Technology is a treatment for certain wide-necked intracranial aneurysms by diverting flow away from the aneurysm neck, reconstructing the parent artery and restoring its natural course.
The Pipeline™ Flex embolization device is indicated for use in the internal carotid artery up to the terminus for the endovascular treatment of adults (22 years of age or older) with small and medium wide-necked saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel.
The product features a permanent mesh cylinders (stent) braided from platinum and tungsten and cobalt-chromium-nickel alloy wires. It uses a guidewire-based delivery system used to place the implant inside the patient.
Medtronic touts its safety record on its website, with numbers indicating different regions of use. According to the site it states: “Pipeline™ Flex is the most studied flow diverter worldwide with a proven safety and efficacy profile.”
Tube Fractures and Wire Pieces can break.
However it has issued this recall in junction with the FDA on July 13, 2021. The problem with both the Pipeline™ Flex Embolization Device and Pipeline™ Flex Embolization Device with Shield Technology is that these devices could break apart and leave fractured pieces inside the patient’s brain bloodstream. Breakage can occur when the device is used to place, retrieve, or move the stent inside a patient.
It’s possible that attempts to retrieve broken pieces could make the patient’s condition worse. Fragments can also cause other serious health issues such as blockage of blood vessels, stroke, and death.
Model Numbers of the Recalled Medtronic Products.
Model numbers associated with the recall are as follows:
- Pipeline Flex Embolization Device: PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350-XX, PED-375-XX, PED-400-XX, PED-425-XX, PED-450-XX, PED-475-XX, PED-500-XX
- Pipeline Flex Embolization Device with Shield Technology: PED2-250-XX, PED2-275-XX, PED2-300-XX, PED2-325-XX, PED2-350-XX, PED2-375-XX, PED2-400-XX, PED2-425-XX, PED2-450-XX, PED2-475-XX, PED2-500-XX
There are 8,825 of these devices being recalled. The distribution date is from April 18, 2019 to August 13, 2020.
As of this FDA Recall there have been 59 reported device malfunction, 10 serious injuries and two deaths.
Not the first FDA recall or Lawsuit for Medtronic.
In 2008, the FDA issued a warning to Medtronic after receiving complaints of problems associated with the Infuse Bone Graft. The company was allegedly promoting the use of this product for off-label purposes; meaning that it was being used for purposes other than for what it was approved. Specifically, the product was allegedly being used in surgeries involving the upper spinal cord and the neck.
This prompted the legal community to act and Medtronic faced its first lawsuit. The lawsuit alleged that Medtronic fraudulently obtained U.S. Food and Drug Administration (FDA) clearance for certain devices used in spinal fusion surgeries.
Defective Medical Device Lawyers Protects Patients.
The defective medical device lawyers at Schmidt National Law Group is aware of this serious FDA Class I recall and is offering free consultations to anyone who may have suffered any injuries, or deaths from the use of the Medtronic Pipeline™ Flex Embolization Device and Pipeline™ Flex Embolization Device.
Contact us today at 1-800-631-5656 or use the 100% secure form on this page.
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