On June 22, 2017, the FDA announced that Vascular Solutions, Inc., a medical device company that manufactures products used in vascular procedures, had issued a worldwide recall of Venture Catheters. The company issued the recall on April 25, 2017, which offers around 4,679 units distributed in the United States.
The FDA has classified this as a Class I recall. This is the most serious type of recall because it involves a situation where “there is a reasonable probability that the use of, or exposure to, a violative product will cause adverse health consequences or death.”
Catheters Can Fill Up with Material and Potentially Cause Blood Clots
Vascular Solutions, Inc., recalled these catheters because their potential to cause a blood clot. According to the company’s press release, an internal investigation revealed that excess material may gather within the inner lumen of the distal catheter tip. During use, “the excess material may separate from the catheter,” the company explained, “and pose a potential risk of embolism [blood clot], which could result in serious injury.”
The company blames this problem on a manufacturing defect, not a design defect. It sent an urgent medical device recall notification to healthcare facilities and distributors, warning them to remove the products from inventory and immediately return them to Vascular Solutions, Inc.
The affected product codes and lots are listed on the FDA’s website and include all unexpired lots of the Rapid Exchange, Over-the-Wire, and Coronary Sinus versions of the product.
Millions of Catheters Recalled in 2016
This is only one of several catheter recalls that have been implemented over the last year. In April 2016, for example, Cook Medical recalled over four million catheters because of the potential for the tip to break off and cause serious injuries.
That same month, Boston Scientific recalled their Fetch 2 Aspiration Catheter because of the potential for the shaft to break in the middle of a procedure. Later that year, Vascular Solutions recalled their Twin-Pass Dual Access catheters because of potential blood-clot injuries, and Medtronic recalled more catheters for the same reason.
Many patients who were injured by these devices have filed lawsuits in an attempt to recover damages.
Venture Catheter Originally Sold by St. Jude Medical
Teleflex acquired vascular Solutions in February 2017. Teleflex is a global provider of medical technologies creating devices in the fields of vascular and interventional access, urology, and cardiac care.
Catheters can be used to deliver saline solutions or diagnostic contrast agents (used during X-rays) into a blood vessel. Each Venture Catheter has a bendable tip that allows the catheter to bend and turn as needed as the physician pushes it through a vein or artery to where it is needed. In surgery, the surgeon can steer, direct, and control the Venture Catheters to access discrete regions of the coronary and peripheral veins and arteries.
Vascular solutions acquired the Venture catheter in August 2012 from St. Jude Medical. At the time, the product was generating around $3 million in annual worldwide sales.