Medtronic announced a recall of its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology in February of 2020. The company cited risks that the medical devices can break while being used on patients. The broken pieces could become trapped in the patients’ bloodstreams. Adverse health conditions and other serious complications like blocked blood vessels, stroke, and death could easily occur. The U.S. Food and Drug Administration (FDA) determined the recall required a Class I Recall designation, which is the most severe of FDA recall programs. If you or a loved one received a Medtronic Pipeline Flex Embolization Device, with or without Shield Technology, and after that suffered life-threatening health problems because of the device, you may be eligible to join in a Medtronic Pipeline Flex Embolization Device lawsuit.
The FDA Class I FDA Recall of Medtronic´s Pipeline Flex Embolization Device
The FDA’s notice of recall describes the device recalled as a flexible mesh cylinder made from wires that doctors use to treat brain aneurysms that have either bulged or ballooned out from the sides of the affected blood vessel. The device was designed to help doctors insert an implant to alleviate or eliminate the risk that the aneurysm might erupt and kill the patient. Medtronic distributed 822 recalled medical devices from November 6, 2019, to February 7, 2020.
The FDA said the delivery system could break as the surgeon is trying to insert the device and get stuck in the patient’s blood vessels in the brain. Broken pieces can lead to life-threatening injuries or even death from stroke, bleeding, or brain injury. Additionally, attempts by doctors to remove the broken pieces of the stent could cause further harm to the patient and magnify the dangers of the fractured implant.
The FDA confirmed that Medtronic identified the defect with the recalled devices. Medtronic said that the device is prone to breaking at the end of the Pipeline Flex device. Medtronic claims that the defect was created by a weak bond between the parts of the device. The medical device manufacturing giant also claimed that the weakened bond occurred in those devices distributed over the last few months. The company did not say why the bond between the components weakened. The weak bond could be caused by insufficient use of bonding material, defective bonding material, or a defect in the assembly process.
Medtronic maintains that patients who were treated successfully with the device are not in danger or live with an increased threat that a piece of their stent could break and lodge in the vascular structures in their brain. Notwithstanding, the FDA indicated that the agency received 50 adverse event reports. Ten (10) of the adverse event reports noted an injury to the patient. Sadly, one patient died as a result of the defect between November 1, 2019, and March 1, 2020.
What Should You Do If You or a Loved One was Injured by a Defective Medical Device?
Patients who suffer any injury or the family of someone who dies from a defective medical device has rights. Before pursuing legal action, the injured person must do everything he or she can to mitigate or lessen the damage. Also, injured patients must closely follow their doctors’ orders, so they give themselves the best possible chance to make a complete recovery. Next, you should contact an attorney with experience pursuing product liability claims against massive medical device manufacturers like Medtronic for their defective medical devices. They will understand how to build your case so that you achieve the most desirable outcome possible.
Potential Damages in a Product Liability Lawsuit
The victim of a defective medical device could win monetary compensation for a variety of economic, physical, and emotional injuries, or wrongful death, depending on the situation. Consulting an attorney with tremendous experience holding medical device manufacturers accountable for their actions will thoroughly explain the damages you and your family can recover from a successful lawsuit.
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