FDA Issues Recall of Dual Access Catheters

On Oct. 5, Vascular Solutions, Inc. issued a national recall for its unexpired Twin-Pass Dual Access catheters. Used in catheterization procedures, the products were manufactured between October 2014 and August 2016, and distributed from October 2014 to September 2016.

According to the U.S. Food and Drug Administration (FDA), “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.” The excess material may separate from the catheter when in use, potentially resulting in embolism, and posing the risk of severe injury or death. Of 15,896 devices manufactured, 5,784 have been distributed in the U.S., and approximately 9.2 percent of recalled devices may be affected. No injuries have been reported as a result of this issue at this time.

Read the FDA announcement.

Keywords: Catheterization, Catheters, Embolism, Medical Device Recalls, United States Food and Drug Administration

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