Vascular Solutions issues recall of Twin-Pass catheters
Vascular Solutions initiated a nationwide recall of Twin-Pass Dual Access catheters used in catheterization procedures. All unexpired lots of the product have been 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. 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 or death. No injuries have been reported in association with this issue to date. The recalled products were manufactured from October 2014 to August 2016 and distributed from October 2014 to September 2016. The FDA classified this as a Class I recall. FDA defines Class I recalls as "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."