Vascular Solutions is recalling all Langston Dual Lumen Catheters distributed from July 12, 2019, to March 10, 2020. The catheter is used for the delivery of contrast material into a patient’s blood vessels during medical imaging examinations.
The recall was put into effect because its inner catheter may separate while being used. In an announcement on its website, the FDA identified this as a Class 1 recall, the most serious type.
“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,” according to the FDA. “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.”
The catheters were manufactured from June 22 to Dec. 2, 2019. The move comes after eight complaints were made about the device. There have been no reports of injury or death.
Customers were contacted in large March about the recall. They were advised to “secure and remove” all unused devices. Teleflex, the parent company of Vascular Solutions, will destroy all unused recalled catheters.