Vascular Solutions, Inc., recalled its Venture Catheter due to reports it can potentially cause a blood clot, which may result in serious injury or even death. On June 22, the U.S. Food and Drug Administration (FDA) categorized this as a Class I recall, which is “a situation in which there is a reasonable probability that use of, or exposure to, a volatile product will cause serious adverse health consequences or death.”
The medical device company maintains the problem stems from a manufacturing defects and not a design defect. Vascular Solutions announced the worldwide recall two month earlier in an “Urgent Medical Device Recall notification distributed to purchasers of the affected product.”
Prior Catheter Recalls
In 2016, Twin-Pass Dual Access Catheters were recalled because of excess material left at the tip of the catheter after it was manufactured. The extra material at the catheter tip may break away while it is in the blood vessel, thereby potentially causing blood clots, embolisms, or the migration of the material to vital organs.
In April 2016, Cook Medical issued a recall of its catheters with Beacon Tip technology because of reports of the tip breaking or fracturing. The company had previously recalled certain lots of the catheters in August 2015. According to Cook Medical, most of the fractures or separations were discovered before patients were treated with the catheters.
Bard Peripheral Vascular Inc. Halo One Thin-Walled Guiding Sheaths also received a Class I recall designation because the device may separate during use. In this case, the device can tear blood vessels, which may lead to a life-threatening situation.
The device is a guiding catheter that introduces devices through an incision in the patient’s leg. “The use of affected sheaths may result in prolonged procedure times and an additional surgical intervention to remove detached components from the patient,” the notification states. “The affected product may cause other serious adverse health consequences such as internal tears and perforation to arteries or veins, excessive bleeding, and death.”
National law firm Parker Waichman LLP has extensive experience and success representing clients in medical device injury litigation. Attorneys are available to answer questions for individuals seeking legal information for potential lawsuits.
Fatality due to a Defective Catheter
A woman from Texas died in December of 2016, as a result of an 8-inch fragment of catheter left in her heart in 2007. The husband of the deceased filed a lawsuit against the hospital for failing to remove it for seven years.
Pete Yonkman, the president of Cook Medical said that, “If we cannot tell our customers how to keep our products safe, then we aren’t comfortable leaving them on the market. It’s a risk we’re not willing to take. Patient safety comes first – period.” This statement may broach the topic of medical malpractice.
Controversial 510(k) FDA Approval
Boston Scientific recalled its Fetch 2 Aspiration Catheter due to the potential for the shaft to break during a procedure. In October 2015, the Shuttle Select catheter, also made by Cook, was recalled. The Beacon Tip, the Shuttle Select and the Fetch 2 Aspiration catheters were all approved through the 510(k) fast-track process. This process does not require the strict clinical trials normally required for new products, but must only show that the new product is “substantially equivalent” to a product already approved by the FDA.
The controversy appears when a product does not perform well or has some negative outcomes that come to light only after the product is on the market and may have caused injury. Plaintiffs in litigation often cite adverse effects as a result of insufficient testing for safety and efficacy of a new product. that has been approved through the 510(k) process.
In a press release in August 2012, Howard Root, CEO of Vascular Solutions made a statement that the Venture catheter was a valuable and established clinical tool, but they were limiting sales at that time to allow a complete commercial re-launch in 2013. According to Vascular Solutions, by 2013, the Venture catheter was generating $3 million in global sales, including about $2 million in U.S. sales.
A catheter is a flexible, thin tube inserted into the body to allow the flow of fluid, often used during minimally invasive surgeries. The various uses for catheters include: injecting contrast dye for angiogram procedures; administering medications; and removing small blood clots from arteries and veins (thrombectomy). Catheters are small enough to fit inside a blood vessel to avoid the need for an open, more invasive surgical procedure, the Star Tribune reports.
Legal Information Involving a Catheter Injury
If you or someone you know suffered an injury due to a defective or recalled catheter, you may be eligible for valuable compensation. Parker Waichman offers free, no obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).