MINNEAPOLIS, MN — Vascular Solutions has issued a nationwide recall of Twin-Pass Dual Access catheters because of 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 could break free from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death, according to the company. To date, no injuries have been reported in connection with the affected catheters.
The US Food and Drug Administration posted the recall notice yesterday and is classifying this as a class I recall, for "a situation in which there is a reasonable probability that use of or exposure to a violative product will cause serious adverse health consequences or death."
The Twin-Pass catheter contains two separate lumens and is designed to allow a guidewire to remain in place while the second lumen is used to deliver medication or contrast or to access the side branches.
Vascular Solutions voluntarily initiated the recall September 16, 2016 through an urgent medical device recall notification that identified the specific lots and included instructions on how to return the affected devices.
The company reported that 5784 devices were distributed in the US and that the condition that led to the recall may affect about 9.2% of recalled devices.
A full listing of the recalled lots is available from Vascular Solutions and includes unexpired lots of model numbers 5200, 5210, and 5230, distributed from October 2014 to September 2016.
Adverse reactions or quality problems experienced with use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.
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Cite this: Vascular Solutions Recalls Twin-Pass Dual Access Catheters - Medscape - Oct 05, 2016.