Recall: Vascular Solutions, Inc. Twin-Pass Dual Access Catheters
On 2016-10-04, the FDA announced that Vascular Solutions is conducting a recall on Twin-Pass Dual Access Catheters due to a possible defect. The recalled products were sold under the brand name(s) Vascular Solutions and Inc. during an unspecified time period throughout the regions shown in the map below.
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Company Contact Information:
Name: Vascular Solutions
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Twin-Pass Dual Access catheters
Brand Name(s): Vascular Solutions, Inc.
Reason for Recall: Excess manufacturing material at tip of catheter may pose embolism risk
Official Recall Date: 2016-10-04
Additional information provided by the FDA.gov:
On September 16, 2016, Vascular Solutions, Inc. (Nasdaq:VASCdisclaimer icon), 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. Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.