The U.S. Food and Drug Administration (FDA) has recalled Medtronic’s Pipeline Flex embolization device aneurysm treatment products because the delivery system can fracture while the device is being placed inside the patient. Nadrich Accident Injury Lawyers has been representing defective medical device clients since 1990. Call us today at 800-718-4658 for a free consultation if you or a loved one was injured or killed by a Medtronic Pipeline Flex Embolization Device implantation procedure.
Medtronic Pipeline Flex Embolization Device Defect
Aneurysm Treatment Delivery System Fracture
The Pipeline Flex embolization device is used to treat brain aneurysms which balloon or bulge out of the sides of the blood vessel. The device’s delivery system may fracture while the device is being placed inside the patient, according to the FDA.
Fractured delivery system pieces can be left inside the brain bloodstream of patients. This can worsen the patient’s condition, as can attempts to remove the fractured pieces. These fractured pieces can cause stroke, continued blockage of blood vessels or death.
Medtronic Pipeline Flex Embolization Device Recalls
The FDA announced in March 2020 that 822 Medtronic Flex Embolization Devices and Flex Embolization Devices with Shield Technology had been recalled in the United States due to a risk of device fracture. These devices had been distributed from November 6, 2019 to February 7, 2020. The model numbers of the devices recalled were:
- 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
Then, in September 2021, the FDA announced that 8,825 additional Medtronic Flex Embolization Devices and Flex Embolization Devices with Shield Technology had been recalled in the U.S. due to the risk of delivery system fractures during movement, retrieval or placement of the device. These devices had been distributed from April 18, 2019 to August 13, 2020. The model numbers recalled were the same model numbers recalled in 2020.
The FDA announced that 59 device malfunctions, 10 serious injuries and two deaths were related to the recall.
California Attorneys Handling Medtronic Pipeline Flex Defect Cases
In California, those who manufacture, design or sell defective medical products are strictly liable for injuries the products cause, even when no negligence is involved. Strict liability can be imposed in California for the following product defect types:
• Manufacturing defects
• Design defects
• Inadequate warnings
Manufacturing Defects
Manufacturing defects are defects in the manufacturing process which cause medical products to differ from the intended result of the manufacturer. Products on the market implicitly represent that they will safely perform their intended function. The manufacturers of these products are strictly liable for injuries these products cause due to defects. Plaintiffs in manufacturing defect cases involving these products must prove the following:
• The defendant sold, distributed or manufactured a product;
• The product had a manufacturing defect when the defendant relinquished possession of it;
• The plaintiff suffered an injury;
• The product defect played a substantial role in causing the plaintiff’s injury.
The Pipeline Flex embolization device may have been manufactured defectively.
The California statute of limitations for manufacturing defects is two years from the date when the plaintiff knows or should have known of their injury and the cause of the injury.
Design Defects
Products with design defects are dangerous by design when manufactured as intended without a defect in the manufacturing process. Manufacturers of products with design defects are strictly liable for injuries these products cause under California law, regardless of negligence. Products are defective in design if:
• The product fails to safely perform as ordinary consumers expect when used reasonably or as intended;
• The risk of danger from a design outweighs the design benefits.
To prove liability in the first case, plaintiffs must prove:
• The defendant sold, distributed or manufactured a product;
• The product didn’t perform as safely as its user would expect it to when used reasonably or as intended;
• The plaintiff suffered an injury;
• The product not performing safely played a substantial role in causing the plaintiff’s injury.
To prove liability in the second case, plaintiffs must only prove that the defendant designed the product and the plaintiff’s injury was caused by the product. The defendant must then prove that the design benefits outweighed the risk of danger from the design.
The Pipeline Flex embolization device may be defective by design.
The California statute of limitations for design defects is two years from the date when the plaintiff knows or should have known of their injury and the cause of the injury.
Inadequate Warnings
Product manufacturers are strictly liable for injuries their products cause in California if they knew or should have known of risks inherent in their products and failed to adequately warn consumers of the risks.
Our law firms are investigating whether there is evidence Medtronic knew or should have known how fracture-prone these devices were during surgery and failed to warn the public about it.
The California statute of limitations for inadequate warnings is two years from the date when the plaintiff knows or should have known of their injury and the cause of the injury.
Medtronic Pipeline Flex Embolization Device Lawyers
The aggressive, battle-tested lawyers at Nadrich Accident Injury Lawyers have been representing defective medical device victims and their families for over three decades. Our attorneys work on a contingency fee basis, so we only charge you a fee if we obtain a recovery for you.
Call us today at 800-718-4658 if you or a loved one was injured or killed following implantation of a Medtronic Pipeline Flex embolization device. You can also use the live chat feature or complete the contact form on this page to request a free consultation. Our law firm is located in California, but we are handling Medtronic Pipeline Flex Lawsuit claims throughout the country.
