07.07.14
Minneapolis, Minn.-based Vascular Solutions Inc. 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. 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. 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 to the operator.
To date, there have been two reports of the inner catheter entering the patient's ventricle, requiring retrieval. No injuries have been reported.
A total of 8,580 of the catheters subject to the recall were sold, with approximately 3,847 still unused in the field.
The U.S. Food and Drug Administration (FDA) classified this as a class 1 recall, which is 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.”
To date, there have been two reports of the inner catheter entering the patient's ventricle, requiring retrieval. No injuries have been reported.
A total of 8,580 of the catheters subject to the recall were sold, with approximately 3,847 still unused in the field.
The U.S. Food and Drug Administration (FDA) classified this as a class 1 recall, which is 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.”