Vascular Solutions, Inc. recalled its Twin-Pass dual access catheters after discovering that excessive manufacturing material may remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. The catheters are used in catheterization procedures.
The FDA classified the action as a class I recall, which the agency defines 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.”
The recall includes 15,896 devices, including 5,784 that were distributed in the U.S. and are currently unexpired. The recalled products were manufactured from October 2014 to August 2016 and distributed from October 2014 to September 2016.
Vascular Solutions said that the excess manufacturing material could result in serious injury or death, although the company said that it had not received any reports of injuries. The company said that the condition that led to the recall could affect approximately 9.2 percent of the recalled catheters.
In April, Vascular Solutions recalled specific lots of the company's Guardian II hemostasis valves.