Vascular Solutions recall of Langston dual lumen catheter is ... | 合法醫療器材資訊網

2020年4月30日—TheFDAissuedanoticetodaywarningthatitsrecalloftheVascularSolutionsLangstonduallumencatheterisidentifiedasClassI.

Vascular Solutions, a Teleflex[2] (NYSE:TFX[3]) 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 treat...