April 16, 2015 — OriGen Biomedical has issued a recall for the VV13F Reinforced Dual Lumen ECMO Catheter because it failed and caused a “serious patient injury.”
The problem is that there is a risk that the clear extension tube can separate from the hub when the catheter is inserted, which could require intervention to prevent permanent impairment or damage.
OriGen is aware of one product failure and has received a report of a “serious adverse event” that resulted in a patient injury.
The recalled catheters are used in advanced life-support procedures involving infants and children with cardiac and/or respiratory failure. Extracorporeal membrane oxygenation (ECMO) machines bypass the child’s heart and lungs to allow these organs to heal during some critical illnesses.
The catheters can be used as a single cannula for venous drainage and/or re-infusion of blood in the internal jugular vein, according to the Safety Alert from the FDA..
The products were distributed in California, Texas, Pennsylvania, Michigan, Indiana, Hawaii, Ohio, New York, Kentucky, Oregon, and Florida. They were manufactured on September 22, 2014, and distributed from February 16 to March 26, 2015.
OriGen asks customers to return the product:
“OriGen Biomedical voluntarily recalled OriGen VV13F Reinforced Dual Lumen ECMO Catheters Lot N18549 after becoming aware of a reported adverse event. Customers who have this lot … should return any product that they currently have to OriGen Biomedical.”
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