FDA: OriGen recalls two lots of dual lumen ECMO catheters

Editor's Note

The Food and Drug Administration (FDA) on September 13 announced the recall by OriGen Biomedical (Austin, Texas) of two lots of its VV28F Reinforced Dual Lumen ECMO [extracorporeal membrane oxygenation] Catheters (Catalog number VV28F, Lots N18487 and V18487-1).

The recall was initiated because the catheters have the potential for a separation of the clear extension tube from the hub that it is inserted in. This can result in an intervention to prevent permanent patient impairment/damage.

OriGen is aware of two product failures and has received two complaints associated with this problem.

Separation could result in required intervention to prevent permanent impairment/damage.