Blood clots occur when a gel-like mass of blood forms in response to an injury or cut. When you get hurt, your body naturally forms a blood clot to plug up the damaged blood vessel to stop the bleeding. Sometimes blood clots form within veins which may cause severe damage to limbs and organs. To remove a dangerous blood clot, doctors may utilize a catheter to return the body to normal blood flow. However, doctors have reported life-threatening malfunctions when using the Penumbra JET 7 Catheters. Removing a blood clot is a delicate process with grave consequences if unsuccessful or compromised. Reach out today to speak with one of our knowledgeable attorneys to find out how a Penumbra JET 7 Catheter lawsuit can help you.
Our law firm is currently handling lawsuits on behalf of individuals who have suffered injury or death when using all models of the Penumbra JET 7 Catheters. Lawsuits against the manufacturer claim that the affected devices can malfunction when a stroke patient is undergoing removal of a blood clot.
Penumbra Inc. is a company in California that manufactures different types of medical devices like the JET 7 Xtra Flex Catheter. The FDA cleared the JET 7 Xtra Flex Catheter for the market in 2019. Also, in 2020, the FDA approved the JET 7MAX for sale. Doctors use this catheter to remove blood clots in people who suffered acute ischemic strokes. Catheter candidates include stroke patients that did not respond to clot-busting drugs and require a catheter to help blood flow resume. The catheter enters an artery in the groin and reaches the neck to suction out the clot to restore normal blood flow.
In December 2020, Penumbra urgently recalled all models of Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex). This announcement pulled more than 30,000 JET 7 Xtra Flex catheters from the market. The recall did not apply to the JET 7 Reperfusion Catheter with Standard Tip. This sweeping recall affected the:
Penumbra announced that the tip of the JET 7 Xtra Flex Catheter may be damaged during use. A damaged tip can result in vessel damage, other injuries, and even death. Over 200 reports sent to the FDA in January 2021 detailed catheter complications such as:
Of the 200 reports, 14 people died as a result of the malfunctions. The FDA instructed the public not to use the recalled models and return them to Penumbra. The agency classified this recall as Class I, the most serious type of recall.
Penumbra revealed that it knew of 17 injuries and 14 deaths linked to the damaged catheter tip when it recalled the device. Stroke victims and loved ones of stroke victims filed lawsuits against Penumbra because of the catheter’s malfunction. Injuries related to the JET 7 Xtra Flex Catheter include:
Penumbra issued a voluntary recall for all models of Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) after it received reports of severe injury, including 14 deaths, from malfunctioning catheters. These malfunctions include damage to the distal tip and breakage after injecting contrast, which can result in injury to the vessel. The FDA advised Penumbra to issue a “Notification to Healthcare Providers” about additional warnings and precautions when using the catheters. Despite this warning, Penumbra waited months to officially recall the defective catheters. Many individuals and families of those harmed by JET 7 catheters have filed lawsuits nationwide. These lawsuits allege that Penumbra knew or should have known about the hazardous issues the catheters present for stroke patients and still waited to recall the device. Furthermore, plaintiffs argue that Penumbra produced a defective catheter that jeopardized the already fragile health of stroke patients.
If a Penumbra JET 7 Catheter injured you or a loved one, you may recover compensation for any or all of the following:
Vicitms of Penumbra JET 7 catheters allege that the company manufactured unreasonably dangerous catheters that interfered with blood clot removals and worsened the health conditions of stroke patients. Furthermore, lawsuits accuse Penumbra of ignoring growing reports of injury and death linked to catheters instead of removing the devices from the market. After suffering a stroke, no patient should have to endure further pain and health complications because of a faulty medical device. Consider enlisting the help of a skilled attorney to start your Penumbra JET 7 catheter lawsuit today.
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) 274-0139 or submit an inquiry on this page.
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