Navigating the complex world of medical devices can be daunting, especially when these lifesaving tools don't function as promised. At the Neumann Law Group, we proudly stand up for patients who have been harmed by defective medical equipment like the Venture Catheter. Recent discoveries surrounding the Venture Catheter’s potentially hazardous design have raised serious concerns and placed the spotlight on the vital importance of product safety. Our team is deeply committed to ensuring that manufacturers are held accountable for their oversights and that affected patients receive the justice and compensation they deserve. With our experience handling medical device product liability cases, we're here to guide you every step of the way, offering clarity and support in these challenging times.What is a Catheter?
A catheter is a thin, flexible tube that can be inserted into a body cavity, duct, or vessel to allow drainage, administer fluids or gases, or access by surgical instruments. The process of inserting a catheter is called "catheterization." There are various types of catheters, each designed for a specific purpose.
Vascular catheterization enables doctors to carry out specific diagnostic procedures that can't be done otherwise. These include taking blood samples directly from the heart, assessing blood flow within the heart's chambers, and examining obstructions or irregularities in the blood vessels beyond the heart, like those in the arms and legs.More Information About the Venture Catheter and Its Design Flaws
From May 7, 2015, through March 31, 2017, Vascular Solutions, Inc., a subsidiary of Teleflex Inc., manufactured the Venture Catheter, which was, at the time, a novel piece of medical equipment. The catheter had a specialized tip, which could be manipulated remotely and bent at an angle up to 90°. The controllable tip provided significant maneuverability for moving in and around tight spaces.
However, the Venture Catheter had critical design flaws. Excess material at its tip posed risks: the tip might split during use, and in graver scenarios, fragments of the excess material could detach and enter the patient's vascular system.
When foreign particles drift freely in the bloodstream, it's a severe hazard. The body naturally reacts to foreign intruders by activating its clotting mechanism. While clotting is beneficial for sealing wounds, in the presence of foreign substances, especially along blood vessel walls, it can lead to excessive clotting by stimulating endothelial cells, platelets, and leucocytes. This may result in blood clot formation.
As a result, patients face an increased risk of thromboembolism and foreign body embolisms. A thromboembolism is a dislodged blood clot that moves through the vascular system and causes blockages. Separately, the catheter material itself can obstruct blood flow, leading to a foreign body embolism. Regardless of whether blood flow is wholly restricted, the medical implications are often dire. An embolism can induce a heart attack if it impacts the heart, a stroke if located in the brain, a pulmonary embolism in the lungs, or tissue infarction in other body areas.Is There a Venture Catheter Recall?
Yes, upon discovering the Venture Catheter design flaw, the United States Food and Drug Administration (FDA) initiated a "Class I" recall, immediately stopping the production, distribution, and use of the Venture Catheter. A Class I recall is issued when there's a "reasonable likelihood that using [the medical device] will result in serious health repercussions or fatality." This represents the most critical recall level at the FDA's disposal.Are Manufacturers Liable for Defective Medical Devices?
Yes, manufacturers can be held liable for defective medical devices. When a medical device, such as a catheter or implant, has a design, manufacturing, or marketing defect that causes injury or harm to patients, the manufacturer may be subject to legal action. Patients or their surviving family members can file product liability lawsuits against these manufacturers to seek compensation for injuries, medical expenses, lost wages, pain, and suffering.Has the Venture Catheter Caused You to Suffer a Serious Injury?
If you or a loved one has experienced any of the above-described effects from the use of a Venture Catheter, you may be entitled to significant financial compensation. At the Neumann Law Group, our dedicated team of Venture Catheter defect attorneys have extensive experience litigating complex product liability claims, including those involving defective medical devices and other consumer products. We offer free consultations to all prospective clients, during which we will answer your questions, explain the recovery process, and provide you with an honest assessment of your case. To learn more, and to schedule a free consultation today, give the Traverse City product liability lawyers at the Neumann Law Group a call at 800-525-6386. You can also connect with us through our online contact form. Calling is free, and we will not bill you for our services unless and until we can connect you with the compensation you deserve.