Recall Issued for Spectranetics Bridge Catheter
Spectranetics issued a recall for its Bridge catheter for possible inability to pass the guidewire through the device, resulting in a potential delay of treatment. The FDA determined the cause to be a nonconforming material/component.
The device is used for temporary vessel occlusion of the superior vena cava in applications including perioperative occlusion and emergency control of hemorrhage.
Spectranetics mailed a recall letter to customers on Aug. 8, and an updated letter on Aug. 23.