Langston Dual Lumen Catheter Recalled for Separation Risk ... | 合法醫療器材資訊網

2020年5月5日—UseofdeviceswithaClassIrecallmaycauseseriousinjuryordeath,accordingtotheagency.Thecatheterisusedtorapidlydelivercontrast ...

Vascular Solutions Inc. has recalled the Langston Dual Lumen Catheter because of the risk that the inner catheter may separate during use, according to a U.S. Food and Drug Administration notice.

The FDA identified this as a Class I recall, the most serious type. Use of devices with a Class I recall may cause serious injury or death, according to the agency.

The catheter is used to rapidly deliver contrast dye into the blood vessels during angiographic studies. The device also measures pressure within the blood vessel.

If the inner catheter separates, it could cause serious health conditions, including requiring additional surgical procedures to remove the separated section, damage to the blood vessel or death. If the separation occurs outside the patient’s body, the dye could spray the treating clinicians and lead to an infection that could require treatment.

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