Vascular Solutions Recalls Langston Dual Lumen Catheters

(RTTNews) - Vascular Solutions, Inc. (VASC) said Thursday that it has initiated a voluntary nationwide recall of Langston dual lumen catheters used in catheterization procedures.

The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients.

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 circulation, requiring 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 to the operator.

The specific affected lots of Langston were of Model Numbers 5540 and 5550, were manufactured from January 2014 to April 2014, and distributed from March 2014 to May 2014. A total of 8,580 of the catheters subject to the recall were sold, with about 3,847 still unused in the field.

To date, there have been two reports of the inner catheter entering the patient's ventricle, requiring retrieval. No injuries have been reported.

The U.S. Food and Drug Administration has classified this as a Class 1 recall, defined as, "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."