Langston V2 Dual Lumen Catheter Recalled

July 7, 2014 — The U.S. Food and Drug Administration (FDA) and Vascular Solutions, Inc. have issued a Class I recall for the Langston V2 Dual Lumen Pressure Monitoring Catheter.

The inner catheter can detach from the device hub during use. This may require an intervention procedure to retrieve the separated piece from the patient’s body. No injuries have been reported. However, the problem could cause serious adverse health consequences, including death, if the broken pieces travel in a patient’s bloodstream.

The recall affects approximately 8,500 catheters that were manufactured between January and April and distributed until May. Vascular Solutions has accounted for about 86% of inventory and they have notified customers by letter and phone.

Recommendation:

• Remove affected devices and place them in a secure area.
• Complete and return the “VSI Account Inventory Form” included with the letter.
• Returned devices will be replaced by Vascular Solutions.

For a complete list of affected lot numbers, click here.

What is the Catheter Used For?

According to the recall notification:

“The Langston V2 Dual Lumen Pressure Monitoring Catheter is used to deliver dye (contrast medium) into a patient’s blood vessels during medical imaging tests (angiographic studies) that allow clinicians to see internal body structures. The device also measures pressure within the blood vessel.”

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