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OriGen ECMO Catheter Recall After Patient Seriously Injured

April 16, 2015 — An urgent recall has been issued after a patient was severely injured by an ECMO catheter made by OriGen Biomedical.

OriGen has received one report of a patient who was seriously injured when the catheter failed.

The catheters are used as a single cannula to drain or re-infuse blood into the internal jugular vein. They are intended for use in infants or young children who are on extracorporeal membrane oxygenation (ECMO) machines, which bypass the patient’s heart and lungs to allow these organs to heal during critical illnesses.

According to OriGen, the problem is that:

“These VV13F Reinforced Dual Lumen ECMO Catheters have been found to have the potential for a separation of the clear extension tube from the hub in which it is inserted, which potentially could result in required intervention to prevent permanent impairment/damage.”

The FDA also issued a Safety Alert to announce a recall for Lot N18549, which was made on September 22, 2014 and sold from February 16 until March 26, 2015 in the states of California, Texas, Pennsylvania, Michigan, Indiana, Hawaii, Ohio, New York, Kentucky, Oregon, and Florida.

OriGen asks customers to return the product and report any adverse events.

 

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