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Origen Catheters Recalled Following Reports of Adverse Events

Washington, DC: OriGen Biomedical in conjunction with the US Food and Drug Administration (FDA) is recalling two lots of VV28F Reinforced Dual Lumen ECMO Catheters N18487 and N18487-1 following reports of adverse events associated with the devices.

OriGen Biomedical is aware of two product failures and has received a complaint associated with each of the two product failures. A recurrence of this event could result in serious patient injury, according to the recall notice on the FDA website.

The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less (USA) or less than 29 days (rest of world).

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