Vascular Solutions Inc., has initiated a nationwide recall of its Twin-Pass Dual Access catheters used in cauterization procedures. All unexpired lots are being 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. This excess material may separate from the catheter during use and pose a risk for embolism, which could result in serious injury or death. To date, no injuries related to this recall have been reported.
Affected catheters were manufactured from October 2014 to August 2016 and distributed from October 2014 to September 2016. The recalled products are all unexpired lots of Model Numbers 5200, 5210, and 5230. A total of 15,896 devices have been manufactured, with 5,784 unexpired catheters distributed in the United States. About 9.2 percent of the recalled products are thought to have this defect.
Health care facilities with affected Twin-Pass dual access catheters have been notified of this recall and instructed to remove the products from their inventory and return them to Vascular Solutions.
Health care professionals and patients are encouraged to report any adverse events, side effects, or quality issues related to the Twin-Pass dual access catheters to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.