Vascular Solutions recalls Twin-Pass dual access caths

Vascular Solutions (NSDQ:VASC) said yesterday it initiated a nationwide recall of its Twin-Pass dual access catheters due to a potential for excess material in the catheter that could dislodge and pose a risk for embolism.

The FDA has labeled the recall as Class 1, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the agency.

The recall affects approximately 15,896 products manufactured between October 2014 and August 2016 and distributed between October 2014 and September 2016. Included are all unexpired lots of model numbers 5200, 5210, 5230. A total of 5,784 unexpired products have been distributed in the U.S. and are currently unexpired.

So far, no injuries have been reported in association with the issue, according to a press release from the Minneapolis, Minn.-based company.

Vascular Solutions said it notified customers with the devices on Sept. 16 through an urgent medical device recall notification. The company advised customers with questions about the recall to contact them, and to report any other issues to the FDA.

In April, Vascular Solutions said it initiated a recall of its Guardian II hemostasis valves designed for use in catheterization procedures over an increased risk of air leakage that could lead to air embolism.

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