The US Food and Drug Administration (FDA) has classified Vascular Solutions' recently started voluntary nationwide recalling of Langston dual lumen catheters used in catheterisation procedures as a Class 1 recall.
The catheters are indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites.
Specific lots of the Langston dual lumen catheters were recalled on 23 May because of the potential for the inner catheter to separate from the hub during use and travel into a patient's circulation.
This may require an intervention or surgery to retrieve the separated piece, the company said in a statement.
In addition, the operator may be at increased risk of contact with contrast or bodily fluid, which could result in infection or injury.
According to the company, specific affected lots of Langston were of Model Numbers 5540 and 5550 were manufactured from January to April 2014 and distributed from March to May.
Vascular Solutions said that a total of 8,580 of the catheters subject to the recall were sold, with around 3,847 still unused in the field.
So far, there have been two reports of the inner catheter entering the patient's ventricle, requiring retrieval and no injuries have been reported.
Affected customers have been notified by the company by letter, following-up by phone call and in-person visit as necessary to ensure the return of all available affected products.
Until now, more than 86% of inventory has been accounted for and product is being returned to the company and the notification included instructions on how to return affected products.