The company had initiated a voluntary nationwide recall of specific lots of the Langston dual lumen catheters on 23 May 2014 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.
Additionally, the operator may be at increased risk of contact with contrast or bodily fluid that could potentially result in infection or injury to the operator.
According to Vascular Solutions, the specific affected lots of Langston were of Model Numbers 5540 and 5550. The products were manufactured from January 2014 to April 2014 and distributed from March 2014 to May 2014.
The company said that a total of 8,580 of the catheters subject to the recall were sold, with approximately 3,847 still unused in the field.
Until now, there have been two reports of the inner catheter entering the patient’s ventricle, requiring retrieval and no injuries have been reported.
Vascular Solutions designed the Langston dual lumen catheter 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.
