Vascular Solutions Issues Recall of Catheters Due to Health Risk
excess material may pose risk of embolism
Vascular Solutions has initiated a nationwide recall of Twin-Pass Dual Access catheters.
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.
The recalled products include all unexpired lots of model numbers 5200, 5210, and 5230. A listing of the recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products.
A total of 15,896 devices have been manufactured, with 5,784 currently unexpired devices distributed in the United States.
Vascular Solutions initiated the recall on September 16, 2016 through an Urgent Medical Device Recall notification distributed to purchasers of the affected products.
The notification identified the specific unexpired lots subject to the recall and included instructions on how to return the affected products.
The Food and Drug Administration (FDA) classified this as a Class I recall, defined as "a situation in which there is a reasonable probability that the use of, or exposure to, a volatile product will cause serious adverse health consequences or death."
No injuries have been reported in association with this issue to date.
Consumers with questions may contact Vascular Solutions at (888) 240-6001.