Vascular Solutions, the Maple Grove-based maker of medical devices for the circulatory system, has announced its second high-risk recall this year.
The company publicly announced Tuesday that it was retrieving from the market all unexpired lots of three models of its Twin-Pass Dual Access catheters, which are very thin tubes that can be used during interventional procedures in the heart and legs to deliver two surgical tools to the same vascular site.
More than 15,800 of the Twin-Pass catheters, model Nos. 5200, 5210 and 5230, were distributed worldwide between October 2014 and September 2016. Those include 5,700 that were sold in the U.S. and remain unexpired. The manufacturing defect that sparked the recall affected about 9 percent of the devices.
According to a company news release and a recall notice from the Food and Drug Administration, excess manufacturing material might have been left inside one of the tubes in the Twin-Pass catheter. During a medical procedure, that material could break loose and travel inside the body, creating a risk of sudden vascular blockage known as an embolism.
The FDA classified the action as a Class I recall, the highest-severity category, because such an embolism could result in serious injury or death.
Last April, the FDA classified Vascular Solutions' recall of two U.S. models of its Guardian II hemostasis valves as a Class I action as well.
In that recall, which the company announced in March, several lots of its Guardian II valve were recalled because of a potential defect with an internal seal that could allow air to leak into the device and enter the body, creating the risk of an air embolism.
That recall, affecting model Nos. 8210 and 8211, involved about 26,500 devices, including 5,200 in the United States.
