Certain versions of the Venture Catheters made by Vascular Solutions are being recalled because of some excess material that may split or separate during a procedure potentially harming the patient. Excess material at the tip of the catheter may separate and could enter the patient’s bloodstream. This may result in a serious adverse health consequence such as the development of blood clots, embolism of the excess material to vital organs, or death.
The Venture catheter is designed for directing, steering, controlling, and supporting a guidewire to access veins and arteries in the arms, legs, hands, feet, and heart muscle (myocardium). Certain models may also administer saline fluids or drugs into blood vessels.
On April 25, 2017, Vascular Solutions Inc., sent an Urgent Medical Device Recall letter to all affected customers requesting all catheters in question be returned. After filling out the Customer Inventory Form, a replacement will be provided. Models included Venture RX Catheter (Model 5820), Venture OTW (Model 5821), and Venture CS Catheter (Model 5822). All unexpired lots of the Rapid Exchange (RX), Over-the-Wire (OTW), and Coronary Sinus (CS) versions of the product have been recalled.
Distributing dates were from May 7, 2015 to April 19, 2017 and manufacturing dates were May 7, 2015 to March 31, 2017. In the United States, 7,054 devices were recalled.
How a Catheter Works
A catheter is a thin, flexible 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, the Star Tribune reports.
There have, to date 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of harm to patients, but Vascular Solutions recommended that hospitals not use the affected devices, which should be withdrawn from use and returned to the company.
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catheters are causing serious injuries leading to approximately four million allegedly defective devices to be withdrawn from the market.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 rise.
The degradation of catheters and catheter parts appears to be a major 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 travels to the lungs, heart, or other vital organs, the outcome may be deadly.
Additional Catheter Manufacturer Recalls
Cook Medical, Boston Scientific, Medtronic and Centurion are a few of the manufacturers that have recalled many catheters of various models. 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 Fetch 2 Aspiration Catheter works by clearing blood clots from coronary arteries also by thrombectomy. The long, flexible device pushes through the arteries and vacuums clots from blood vessels. This allows blood to flow more freely by removing any obstructions, reports drugwatch.
The reason given for the recall is the catheter shaft may break prior to or during the procedure, at various points along the device. Should the breakage occur while the device is in a patient, bits of the catheter may block blood supply to the heart or blood vessels, and would need to be surgically removed.
Filing a Catheter Lawsuit
If you or someone you know suffered injuries associated to the use of a catheter, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, please contact Parker Waichman medical device attorneys at 1-800-YOURLAWYER (1-800-968-7529).