Vascular Solutions Recalls Twin-Pass Dual-Access Catheters
Vascular Solutions has issued a recall of their twin-pass dual access catheters, which are used in catheterization procedures, given the potential for excess manufacturing material at the tip of the catheter or within the distal portion of the rapid-exchange lumen to break off from the device.
If the excess manufacturing material separates from the catheter, there is a risk of embolism, which can result in serious injury or death, according to Vascular Solutions. To date, no injuries have been reported with the affected products.
The US Food and Drug Administration (FDA) is classifying the announcement as a Class I recall, which is defined as “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.”
A full listing of the affected lots is available from Vascular Solutions and has been provided to each facility that has purchased the products. The company said that approximately 5,784 devices have been distributed in the United States, with the condition leading to the recall believed to affect approximately 9.2% of recalled catheters. The company initiated the recall on September 16, 2016, through an Urgent Medical Device Recall notification, and the FDA posted the recall on its website yesterday.
The twin-pass catheter consists of two independent lumens and is designed to allow the guidewire to remain in place when physicians need use of the second lumen for the targeted delivery of medication, contrast, or a second guidewire.
Any adverse outcomes or quality issues related to the use of the product can be reported to the FDA’s MedWatch Adverse Event Reporting program.
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Vascular Solutions. Vascular Solutions, Inc. issues recall of twin-pass dual-access catheters. vasc.com/wp-content/uploads/2012/04/VASC-Press-Release-Twin-Pass-Recall-October-4-2016.pdf. Published on: October 4, 2016. Accessed on: October 5, 2016.