China NMPA Product Recall - Hurricane RX Biliary Balloon Dilatation Catheter

On October 21, 2021, the National Medical Products Administration (NMPA) reported a voluntary recall initiated by Boston Scientific (Shanghai) Co., Ltd. concerning specific batches of its Hurricane RX Biliary Balloon Dilatation Catheter. The company observed an increase in complaints regarding balloon perforation. An investigation determined that a new radiopaque marker attachment process was the cause, potentially leading to balloon material perforation due to interaction with the marker, especially when used at certain endoscope angles. The primary consequence of this issue is the potential for prolonged instrument change times during surgery, thereby extending the overall surgical duration. Fortunately, Boston Scientific confirmed no patient injuries have been reported related to this defect. In response, Boston Scientific proactively issued a voluntary Class II recall for the affected devices, indicating a situation where the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Further details are available in the Medical Device Recall Event Reporting Form.