FDA Class I Recall: Vascular Solutions, Inc. Langston Dual Lumen Catheter due to risk of separation during use
Vascular Solutions, Inc. is recalling the Langston Dual Lumen Catheter because there is a potential the inner catheter may separate during use. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall because use of these devices may cause serious injuries or death.
If the inner catheter separates, it could cause serious health conditions including additional surgical procedures to remove the separated section, damage to the blood vessel or death. If the inner catheter separates outside of the patient’s body, the dye could spray the doctor and lead to an infection that may require the doctor to receive treatment.
There have been eight complaints and no reports of injury or death.
Lot Numbers: Lots distributed between July 12, 2019 and March 10, 2020
Model Number: Model 6F 5540
Manufacturing Dates: June 22, 2019 to December 02, 2019
Distribution Dates: July 12, 2019 to March 10, 2020
Devices Recalled in the U.S.: 4,304
Date Initiated by Firm: March 16, 2020
The Vascular Solutions, Inc. Langston Dual Lumen Catheter is used for the rapid delivery of dye (contrast material) into a patient’s blood vessels during medical imaging tests (angiographic studies) to allow clinicians to see internal body structures. The device also measures pressure within the blood vessel.
Teleflex (Vascular Solutions, Inc.’s parent company) will destroy any unused recalled devices.
