Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Vascular Solutions, Inc. Issues Recall of Langston Dual Lumen Catheters
Chief Executive Officer
Vascular Solutions, Inc.
FOR IMMEDIATE RELEASE - May 23, 2014 - 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.
Healthcare facilities that have the affected Langston dual lumen catheters should remove the products from their inventory and return them to Vascular Solutions. A list of recalled lots is available from Vascular Solutions and has been provided to each facility that purchased the affected products. 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 approximately 3,847 still unused in the field.
Vascular Solutions initiated the voluntary recall and notified its affected customers by letter, following-up by phone call and in-person visit as necessary to ensure the return of all available affected products. To date, over 86% of inventory has been accounted for and product is being returned to the company. The notification included instructions on how to return the affected products.
The U.S. Food and Drug Administration (FDA) classified this as a Class 1 recall. FDA defines Class 1 recalls 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.”
Consumers with questions may contact Vascular Solutions by phone at 1-888-240-6001 Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. Central Time or by email at email@example.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:
- Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or
- Call FDA 1-800-FDA-1088
About Vascular Solutions
Vascular Solutions, Inc. is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company’s product line consists of more than 80 products in three categories: catheter products, hemostat products, and vein products. Vascular Solutions delivers its products to interventional cardiologists, interventional radiologists, electrophysiologists and vein specialists through its direct U.S. sales force and international independent distributor network.
For further information, visit www.vasc.com.