Vascular Solutions Inc. has begun a voluntary nationwide recall of its Langston dual lumen catheters used in heart procedures.
CEO Howard Root said in an interview late Thursday that there have been no injuries and that there will be no adverse financial consequences for the Maple Grove company.
To date, there have been two reports of the inner catheter entering a patient's ventricle, requiring retrieval.
"This was a supplier component that was out of manufacturing specification," Root said. "We got it corrected, and now we're making them again."
The Food and Drug Administration classified this as a Class 1 recall, "a situation where there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death."
Root said the Langston dual lumen catheter trade represents about $5 million in annual revenue out of about $120 million in total sales.
"It's not a material financial matter for the company," he said.
The Langston dual lumen catheter is used for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites, the company said.
Specific lots of the products have been recalled because of the potential for the inner catheter to separate from the hub during use and travel into the patient's circulatory system. This may require an intervention or surgery to retrieve the separated piece. In addition, the operator may be at increased risk of contact with contrast or bodily fluid, which could potentially result in infection or injury.
Vascular Solutions said it notified affected customers by letter and phone. More than 86 percent of inventory has been accounted for and product is being returned. The affected lots were manufactured between January and April, and distributed through May.
A total of 8,580 of the catheters subject to the recall were sold, with approximately 3,847 still unused in the field.