Specific lots of the device failed to meet in-house balloon pressure testing. There were no serious patient injuries or deaths reported. While not observed or reported, additional potential risks or harms may include delay to treatment, hemorrhaging, blood loss, bleeding, or perforation of vessels. The most foreseeable sequence of events would be balloon rupture during inflation while under close monitoring and traditionally direct fluoroscopic visualization, resulting in careful removal of the malfunctioned device and replacement with a new balloon catheter for procedure completion. Recall start date: September 19, 2024
RecallTracker