A worldwide recall has been issued by Teleflex Inc. of over 4,000 surgical catheters in an action that has been designated by regulators as a Class 1 recall, the most serious category. A Class 1 recall is a situation in which there is a “reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences,” according to the U.S. Food and Drug Administration (FDA). The catheters are made by the Maple Grove subsidiary, Vascular Solutions.
What is a Catheter?
A catheter is a flexible, thin tube inserted into the body to allow the flow of fluid, often used during minimally invasive surgeries. The uses of catheters include: administering medications; injecting contrast dye for angiogram procedures; and removing small blood clots from arteries and veins (thrombectomy). They are small enough to fit inside a blood vessel to avoid the need for an “open” surgical procedure, reports the Star Tribune.
The catheters affected by the recall are designed to deliver tiny surgical devices to the blood vessels in the heart and legs, and to manually deliver saline or diagnostic contrast liquid to the body during medical procedures.
In April, Vascular Solutions announced that it was voluntarily recalling 4,679 units of Venture catheters because of a risk that “excess material” inside the device may separate or break free during a medical procedure and enter the body. This could create a risk of embolism, which is an obstruction of an artery, typically by a clot of blood or an air bubble.
To date, there have been no reports of harm to patients, but Vascular Solutions recommended that hospitals not use the affected devices, which should be withdrawn from use and returned to the company.
The corrective action applied to unexpired lots of Venture RX Model 5820, Venture OTW Model 5821, and Venture CS Model 5822 catheters that carry one of 73 lot numbers listed in the safety letter.
Wayne, Pennsylvania-based Teleflex Inc., acquired Vascular Solutions on February 17, from the longtime Minnesota device firm Vascular Solutions in a $56-per-share deal valued at over $1 billion, according to the Star Tribune.
National law firm Parker Waichman LLP has extensive experience representing clients in medical device injury litigation. Attorneys are available to answer questions for individuals seeking legal information for potential lawsuits.
Risks Associated with Defective Catheters
There are some risk factors indicating defective catheters are causing serious injuries prompting approximately four million allegedly defective devices to be recalled from the market. Taking into consideration the number of reasonably common medical procedures for which catheters are routinely used, it is fair to assume catheter injury lawsuits will continue to emerge.
The degradation of catheters and catheter parts appears to be a primary problem. This breakdown of materials may lead to the fracture of catheter tips and fracture and separation of the catheter components. When material, or pieces of the catheter break away from the device and float freely in the bloodstream, serious injury or death may occur for some patients. If this free-floating material migrates to the lungs, heart, or other vital organs, the outcome may be deadly.
Other Catheter Manufacturer Recalls
Cook Medical, Boston Scientific, and Centurion are a few of the manufacturers that have recalled many catheters of various models. Medtronic is an additional manufacturer that has initiated a recall.
In March 2016, a Class I recall was issued for Boston Scientific’s Fetch 2 Aspiration Catheter due to a risk of shaft breakage. The device, also known as a thrombectomy catheter is used to remove small blood clots from coronary arteries during surgery. According to the alert, the devices were manufactured between June 11, 2014 and February 19, 2016 and 21,155 units were affected.
Another Class 1 recall issued December 9, 2016, involved the Centurion Convenience Kit containing Multi-Med Single Lumen Catheters. The recall was issued because there may have been an excess of materials at the tip of the catheter due to the manufacturing process. This could lead to serious complications if the excess material were to enter the patient’s bloodstream.
“The catheters have a potential for excess material to remain at the tip of the catheter from the manufacturing process,” the recall alert stated. “If this occurs, the excess material may separate from the catheter during use and could enter the patient’s bloodstream. This can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.”
Legal Information Involving a Catheter Injury
If you or someone you know suffered an injury related 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).