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PROBLEMS WITH COCHLEAR IMPLANT DEVICES FROM ADVANCED BIONICS CORPORATION
Some cochlear implants devices from Advanced Bionics are reported to have a risk of moisture that “potentially results in dendrite growth, corrosion and ultimate failure of the device.” [“Warning Letter” by FDA, February 1, 2005] Learn more about cochlear implant devices from: 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.

Product Defect Lawsuit
If you have a cochlear implant device that is defective because of moisture or corrosion that is causing or has caused you injury, please call us to find out your rights.

Under California law, the manufacturer of a defective product is responsible to pay for all damages caused by their defective product.

Advanced Bionics Corporation is located at 12740 San Fernando Road, Sylmar, California 91342 in Sylmar, California, which is in the County of Los Angeles.