History of Moisture at Advanced Bionics
Sept. 24, 2004: Because of the “potential presence of moisture” in the internal circuitry of its cochlear implants, Advanced Bionics issued a recall on September 24, 2004, of its all of its cochlear implant devices that were still on the shelf and that had not yet been surgically implanted. According to the press release, defective Advance Bionic surgical implant devices that had already been surgically implanted, were to be left in the person until pain, noise or failure occurred. You can the read the recall press release.
Feb. 1, 2005: FDA inspections at the Advanced Bionics plant showed that the cochlear implant devices were “adulterated” with entrapped moisture in the devices that could be due to manufacturing deficiencies, inadequate failure analysis, and overall quality system deficiencies. FDA findings included a lack of training and inspection related to the manufacture of these devices. You can read the warning letter.
Mar. 10, 2006: Because of a high “moisture-related device failure” rate, Advanced Bionics again issued a recall on March 10, 2006, of certain of its cochlear implant devices that were still on the shelf and that had not yet been surgically implanted. The defective Advanced Bionics devices that had already been implanted were to be left in the person until problems developed. You can read the recall notice and the FAQ.