In May 2014, the U.S. Food and Drug Administration classified the Vascular Solutions, Inc. Langston dual lumen catheter Model Numbers 5540 and 5550 as a Class 1 recall, meaning that it is 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.”
As of July, 86% of the inventory has been recovered through notifications by phone call and letter to the victims of the affected products. A total of 8,580 of these catheters were sold to the public and 3,847 remain unused in the field.
While no of injuries have been reported, two reports of the inner catheter entering the patient’s ventricle sparked the recall of the defective catheters. According to the FDA, “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.”
Information such as this can be life-changing and must be viewed with the utmost care and respect. Here at Charles Boyk Law Offices we have helped countless victims receive the compensation they deserve because of defective products such as these catheters. Our attorneys are experienced, careful, and detailed to provide the right “treatment” to our “patients.” We hope that in the future, we can prevent accidents and injuries from happening.
If you or anyone you know has experienced any issues relating to these catheters, please contact us at 800.637.8170. We believe that your safety is our first concern and that, in the event of injury, you receive the proper compensation you deserve.