A worldwide recall of Venture catheters has been voluntarily initiated by its Teleflex’s Vascular Solutions subsidiary. Vascular Solutions, is the manufacturer of Venture catheters, which are designed for use in catheterisation procedures, to direct, steer, control, and support a guidewire to access discrete regions of the coronary and peripheral vasculature. Two versions may also be used for manual delivery of saline solution or diagnostic contrast agents.
The US Food and Drug Administration (FDA) classified this as a class I recall, implying “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 or death.”
The worldwide recall affects 4,679 units distributed in the USA. All unexpired lots of the Rapid Exchange (RX), Over-the-Wire (OTW), and Coronary Sinus (CS) versions of the product have been recalled due to the potential for excess material to be present within the inner lumen of the distal catheter tip. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury. No serious injuries or death have been reported in association with this issue to date.
Vascular Solutions, initiated the recall through an Urgent Medical Device Recall notification distributed to purchasers of the affected products. Healthcare facilities with affected Venture catheters have been advised to remove the products from their inventory and return them to the company. The notification identified the specific unexpired lots subject to the recall and included instructions on how to return the affected products to Vascular Solutions.