The FDA issued a notice today warning that its recall of the Vascular Solutions Langston dual lumen catheter is identified as Class I, the most serious kind of recall.
Vascular Solutions, a Teleflex (NYSE:TFX) subsidiary, designed the Langston dual lumen catheter for the rapid delivery of dye into blood vessels during medical imaging tests, allowing physicians to see internal body structures. The device also measures the pressure within the blood vessel.
The company is recalling the catheter because of the potential that the inner catheter may separate during use, which can cause serious health conditions, including additional surgical procedures, damage to the blood vessel or death.
If the inner catheter separates outside of the patient’s body, the doctor could be sprayed by the dye, leading to an infection that may lead to the need for the doctor to receive treatment. So far, Vascular Solutions listed eight complaints with no reports of injury or death.
The affected model number, Model 6F 5540, was included in lots distributed between July 12, 2019, and March 10, 2020. The affected devices were manufactured between June 22, 2019, and Dec. 2, 2019.
So far, Vascular Solutions recalled a total of 4,304 devices in the U.S. after initiating the recall on March 16, 2020.
Between March 26 and March 31, Vascular Solutions contacted customers informing them of the recall, urging users to secure and remove all unused affected devices. Teleflex intends to destroy any unused recalled devices, according to an FDA release.