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08-24-2010, 10:30 AM #1
Integra Issues URGENT Worldwide Recall of NeuroBalloonTM Catheter
Integra LifeSciences Corporation, Plainsboro, New Jersey, has initiated a worldwide recall of the NeuroBalloon Catheter. There were a total of 1,924 units distributed, 258 in the United States of America 1,586 in the European Union and 80 in countries. A total of eight (8) complaints regarding the inflation or deflation of the NeuroBalloon Catheter were received by Integra. All complaints occurred outside the United States. No patient injuries have been reported. As a result of the investigation performed by Integra, it was determined that this condition could exist during pre-implant testing or during the procedure. Integra issued a voluntary recall of the affected lots of the NeuroBalloon Catheter on July 2, 2010.