OriGen—Reinforced Dual Lumen ECMO Catheters: Clear Extension Tube May Separate from Blue Hub Connection, Potentially Leading to Massive Blood Loss

ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.

In a March 30, 2015, Urgent Medical Device Recall letter submitted by an ECRI Institute member hospital, OriGen states that the clear extension tube may separate from the blue hub connect on on the catheters below. OriGen further states that the separation may result in massive blood loss from the patient and massive air entrainment into the ECMO circuit, potentially necessitating removal of the patient from ECMO support for a period of time to repair the circuit and replace the catheter. If this results in a prolonged period of time off of support and/or an inability to repair the circuit or replace the catheter, the patient may sustain serious injury or death. The manufacturer has not confirmed the...