The Board of Pharmacy instituted a nationwide recall on Langston dual lumen catheters used in catheterization procedures on the behalf of Vascular Solutions.
Vascular Solutions is an innovative medical device company which has the main focal point on promoting and maturing coronary and peripheral vascular procedures. The company has an inventory of approximately 80 products or more. The products are partitioned into three classes: (1) catheter products, (2) hemostat products and (3) vein products. Vascular Solutions has a direct U.S sales force and international independent distributor network in which the company delivers its products to interventional cardiologist, interventional radiologist, electrophysiologist, and vein specialists. For further information, visit http://www.vasc.com
The Langston lumen dual catheters are designated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. The pressure measurement of this degree is usually used for determining transvascular, intravascular and intraventricular pressure gradients.
According to the Board of Pharmacy only specific lots are being recalled, due to the potential of the inner catheter to separate from the hub during use and can travel into the patient's circulation. This would require intervention or surgery to redeem the separated piece. No injuries have been reported however there have been 2 different cases where retrieval of the inner piece from the patient's ventricle but again without injury.
A list is available of the recalled lots at each facility that purchased the affected products, which were purchased from January 2014 to April 2014 and distributed from March 2014 to May 2014. Models include numbers 5540 and 5550. A total of 8,580 catheters were sold with an estimated 3,847 still unused in the field as of July 13, 2014. There has been an 86 percent of inventory which has been recovered.
Consumers with questions or further concerns are strongly urged to contact Vascular Solutions by phone 1-888-240-6001 Monday-Friday 8:00-5:00 p.m central time. http://www.fda.gov/Safety