Advanced Bionics Corporation Recalls
Showing 1-2 of 2 recalls
Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options.
Battery pack may overheat and cause patient burns.
Notification letters were sent to all users and affiliates on July 27, 2004. Initially customers were informed that they will receive a retrofit kit. Firm decided to actually recall the battery packs and sent recall letters on August 10, 2004. All Auria Battery Packs are to be returned per instructions in the recall letters. Firm rerecalled powerpaks that had been repaired since FDA review has found that repairs are not sufficent to address all potential adverse events concieveable. The latest recall letter was sent May 11-12, 2005
Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System
A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit.
Firm has notified all consignees and thier clinicians to provide them with the labeling addenda. Patient notices were sent by FedEx or by US Mail and clinicians were faxed the notice.