Vascular Solutions Hit With Another Class I Recall

This time, the recall involves nearly 16,000 catheters. 

Maureen Kingsley

A potential defect in some of Vascular Solutions's dual-access catheters may pose a risk of embolism in patients, the Maple Grove, MN-based company has announced. 

Vascular Solutions initiated a recall of the Twin-Pass dual-access catheters on September 16; the company says FDA has designated the recall as Class I level.

The company has recalled all unexpired lots of Twin-Pass catheter model numbers 5200, 5210, and 5230, manufactured between October 2014 and August 2016, with15,896 total devices affected. Nearly 6000 (more than one-third) of the recalled catheters were distributed in the United States; distribution occurred between October 2014 and September 2016.

The company says the condition that led to the recall may affect approximately 9.2% of recalled devices, and it has notified each facility that received the catheters in question. (FDA posted the recall notice online this week.)

Vascular Solutions attributes this voluntary recall, its second in six months, to a "potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen," according to FDA. (The type of catheter involved in the recall features an additional, second lumen used for targeted delivery of medication or contrast agent. It is also meant to support the device's side branches.)

"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," FDA says. To date, no injuries or deaths have been reported in association with this problem.

It's been an eventful year for Vascular Solutions. In March, the company voluntarily recalled 26,550 Guardian II hemostasis valves used in catheterization procedures. The recall, which involved 5283 devices distributed in the United States, was also categorized as Class I by FDA.

The recalls come after a tough but ultimately successful legal battle for Vascular Solutions's CEO Howard Root. Root in February was found not guilty in federal court on all charges in a criminal prosecution concerning alleged off-label promotion of the company's Vari-Lase Short Kit, a product for treating varicose veins. Shortly thereafter, the Minneapolis Star Tribune published a scathing editorial written by an exonerated but irate Root, in which the CEO characterized his experience this way: "The malicious way the feds went after me and my company in a felony 'off-label' medical-device case should be a warning to us all."   

Maureen Kingsley is a contributor to Qmed. 

Like what you're reading? Subscribe to our daily e-newsletter.

[Image by Chris Newmarker/Qmed]