FDA designates recall of dual lumen catheters as class 1
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The FDA has designated Vascular Solutions’ recall of a dual lumen catheter used to rapidly deliver contrast material during angiographic studies as a class 1 recall, the most serious kind.
The recall affects 4,304 catheters (Langston Dual Lumen Catheter) distributed and manufactured in the United States between June 22, 2019 and March 10, 2020, according to a safety alert from the agency.
The catheter, which is used to deliver contrast agents into blood vessels during angiographic studies, was originally recalled due to the inner catheter potentially separating during use. Detachment may lead to additional surgeries to remove the separated section, in addition to damaged blood vessels or death, according to the agency. The dye can also spray the doctor if the inner catheter separates outside of the patient’s body, which may lead to an infection requiring treatment.
The company has received eight complaints with no reports of injury or death, according to the agency.
Vascular Solutions emailed or mailed information to their customers from March 26 to 31, 2020, alerting them of the affected model, device and lot numbers, and instructions on how to return the affected catheters, according to the alert, which noted that the parent company, Teleflex, will destroy recalled devices that were not used.