Vascular Solutions Recalls Catheter Due to Defect
Vascular Solutions is conducting a voluntary Class 1 nationwide recall of its Langston dual lumen catheters, due to the potential for the inner catheter to separate from the hub during use and travel through the patient's circulatory system.
“This may require a procedure to retrieve the separated piece from the patient’s vascular system,” according to a recall notice posted to the FDA’s website on July 3.
Minneapolis, Minn.-based Vascular Solutions alerted customers by letter on May 23, instructing them to return affected product to the company. Eighty-six percent of the affected inventory has been accounted for and returned, according to the devicemaker.
Vascular Solutions said it has received two reports of the inner catheter entering the patient's ventricle, resulting in surgical retrieval. No injuries have been reported, however.
The Langston dual lumen catheter is used to deliver contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This pressure measurement aids in determining transvalvular, intravascular and intraventricular pressure gradients.
The affected lots were manufactured from January 2014 to April 2014, and distributed from March 2014 to May 2014. A total of 8,580 of the affected catheters were sold, with roughly 3,847 still unused in the field, the company said. — Kellen Owings
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