A brain aneurysm is a weakened blood vessel that fills with blood and bulges. This ballooning blood vessel can burst and result in bleeding in the brain. A ruptured brain aneurysm is a serious matter that requires immediate medical attention. Surgeons may insert a flexible tube called a stent to divert blood away from the aneurysm. A stent is a critical tool that can save someone’s life in the event of a ruptured aneurysm. But the Medtronic Pipeline Flex Embolization Device has caused multiple injuries and deaths.
Our law firm is currently handling lawsuits on behalf of individuals harmed by the Medtronic Pipeline Flex Embolization Device.
Medical device company Medtronic introduced the Pipeline Flex Embolization Device in 2011 with the FDA’s approval. This device is a type of stent intended to treat brain aneurysms. The Pipeline Flex Embolization Device consists of a mesh cylinder made of braided platinum, tungsten, and cobalt-chromium-nickel alloy wires. Inserted at the base of the aneurysm, this stent stops blood flow to the aneurysm by redirecting it.
In February 2020, Medtronic recalled its Pipeline Flex Embolization Device. The recall also applied to the Medtronic Pipeline Flex Embolization Device with Shield Technology. But this model is not distributed in the United States. The FDA identified this as a Class I recall, the most severe recall. Medtronic issued the recall after reports of the delivery system fracturing while implanting the stent inside the patient. Fractured pieces can enter the patient’s brain bloodstream, and retrieving the pieces could worsen the patient’s condition.
This recall originally included 822 devices in the United States. By July 2021, the expanded recall had applied to 8,825 devices.
The FDA received 59 reports of device malfunctions, 10 injuries, and 2 deaths related to the recalled device. If the delivery system fractures, the patient may experience:
If a fractured Medtronic Pipeline Embolization Device harmed you or a loved one, you may qualify for a lawsuit. A Medtronic Pipeline Embolization Device lawsuit can help you recover compensation for:
Continuous recalls plague Medtronic products. Many of these successive recalls fall into the FDA’s Class I category. The medical device company continues to design and manufacture defective products that may cause severe harm to patients and even produce fatal outcomes for some. If a Medtronic Pipeline Embolization Device injured you, you deserve to take action.
The Lake Law Firm was founded by Edward J. Lake, Esq., a personal injury lawyer for over 25 years. Our dedicated team of attorneys is committed to seeking justice on behalf of those who have suffered injury or death due to the negligence of others. Our experienced attorneys handle many different types of pharmaceutical drugs, medical devices, and other defective products. The lawyers in our firm have helped collect millions of dollars for their clients. The Lake Law Firm will advocate for you and your rights. Please contact us for a free confidential case evaluation at (888) 525-3529 or submit an inquiry on this page.
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