Vascular Solutions has issued a nationwide recall of its Twin-Pass dual access catheters, which FDA has classified as a Class I recall – the most serious type of recall because use of the device could lead to serious adverse events or death.
The company said the product was recalled because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. The excess material could separate and pose a potential risk of embolism. No injuries have been reported.
The recalled products are all unexpired lots of model numbers 5200, 5210 and 5230. They were manufactured from October 2014 to August 2016; 15,896 products were manufactured, and 5,784 were distributed in the U.S.
Healthcare facilities were advised to remove the products from their inventory and return them to Vascular Solutions. The condition that led to the recall may affect 9.2 of the recalled devices.