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You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA). This information has recently been updated and is now available.
10/04/2016 06:48 PM EDT
On September 16, 2016, Vascular Solutions, Inc. (Nasdaq:VASC), initiated a nationwide recall of Twin-Pass Dual Access catheters used in catheterization procedures. 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. No injuries have been reported in association with this issue to date.
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