Venture Catheter Recall Issued Over Reports of Tip Splitting, Separations

More than 7,000 catheters have been recalled due to a risk that excess material at the end of the tip of the catheter may separate during use, potentially resulting in serious adverse health consequences or death.

A Vascular Solutions Venture catheter recall was announced by the FDA on June 21, after recognizing the potential for the catheters’ ends to break and separate during use, allowing excess materials to travel through veins or create blood clots, among various other injuries.

The recall notice follows an Urgent Medical Device Recall letter that was sent to affected customers by Vascular Solutions Inc. on April 25, informing customers of the potential risk associated with the catheter tips breaking.

The catheters are intended for directing, steering, controlling and supporting a guidewire to access veins and arteries within the arms, legs, feet, hands, and heart muscle. Certain models are designed to also administer fluids or drugs into the patients’ blood vessels.

In the event the catheter tips split or separate during use, excess material at the tip could enter the patient’s bloodstream, leading to adverse health consequences such as blood clots, embolism, damage to vital organs, or death.

The recall includes Venture RX catheters with model number 5820, Venture OTW catheters with model number 5821, and Venture CS catheters with model number 5822. The devices were manufactured by Vascular Solutions Inc., from May 7, 2015 through March 31, 2017, where they were distributed for sale to healthcare facilities across the United States from May 7, 2015 through April 19, 2017.

According to the FDA recall notice, an estimated 7,054 recalled Venture catheters were distributed for sale throughout the U.S.

Vascular Solutions Inc., has initiated its notification process to inform affected customers and patients of the dangers associated with the catheters. Customers are being instructed to identify and remove any recalled Venture catheters from their inventory and to contact Vascular Solutions at 1-888-240-6001 or email them at customerservice@vasc.com for information on how to receive a free credit.