OriGen Biomedical recalled one lot of 51 VV13F Reinforced Dual Lumen ECMO Catheters, according to a recall alert posted on the U.S. Food and Drug Administration’s (FDA’s) website. The devices were recalled due to the risk of the clear extension tube separating from the hub in which it is inserted. Intervention may be needed to prevent permanent impairment or damage if this occurs. The recall affects lot N18549, which expires 09/2018. OriGen knows of at least one product failure, which is associated with a serious adverse event that led to a serious patient injury, the recall indicated.
The catheters used during extracorporeal life support procedures lasting six hours or less in the Neonatal Intensive Care and Pediatric Intensive Care ECMO centers. They are used as a single cannula to re-infuse blood in the internal jugular vein and for venous drainage.
The notice advises customers to return the device. The product was distributed to ECMO sites in the following states: California, Texas, Pennsylvania, Michigan, Indiana, Hawaii, Ohio, New York, Kentucky, Oregon and Florida.