The following is the timeline for the Advanced Bionics HiRes90k cochlear implant recall:
September 24, 2004: The first recall of the device is made by Advanced Bionics because of a “potential presence of moisture” in the internal circuitry of its Vendor B model cochlear implants. This recall included, supposedly, all cochlear implant devices on its shelf that had not yet been surgically implanted. This recall is clearly and plainly announced in this FDA Press Release, available by CLICKING HERE. As stated in the Press Release:
Boston Scientific Corporation (NYSE: BSX) today announced that its subsidiary, Advanced Bionics Corporation of Sylmar, California, is voluntarily recalling worldwide all unimplanted CLARION® and HiResolution® cochlear implants. Boston Scientific acquired Advanced Bionics in June. The recall does not affect patients who have already received a cochlear implant. The Company is recalling the devices due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning. The Company is not aware of any patient injuries resulting from the potential presence of moisture, but the malfunction may require replacement of the device. The total number of devices shipped but not implanted is estimated to be 440. The Company is working with the U. S. Food and Drug Administration and is notifying officials in other countries.
The recalled devices include all unimplanted CLARION and HiResolution models. The Company initiated the recall after a review of internal complaint records and analysis of returned product revealed the potential problem.
February 1, 2005: Food and Drug Administration inspections at the Advanced Bionics facility showed numerous defects with the Hi Res 90k model, including moisture issues and lack of testing and management oversight issues. Training and inspection were also highlighted in the eleven page warning letter. The District Director of the FDA for Los Angeles, CA highlighs that warnings included a “failre to conduct management reviews” and “a significant manufacturing deciciency, moisture being hermetically sealed in the Hi Res 90K cochlear implant” which “has not been addressed in management reviews, although it was known that devices distributed with weld dates from August 2002, were suspect devices.” As stated in the warning letter, “the presence of mositure potentialy results in dendrite growth, corrosion, and ultimate failure of the device.” You can read the entire warning letter by CLICKING HERE.
March 10, 2006: Advanced Bionics issued a second recall on March 10, 2006 because of “moisture-related device failure rate,” or specifically that”these (HiRes 90k) implants may be linked to an elevated risk of moisture-related device failure.” In a sense, defective Advanced Bionics devices that had already been implanted in patients were to be left INSIDE the patient until a problem developed. The second recall notice can be found by CLICKING HERE. You can also vire a Frequently Asked Questions page by CLICKING HERE.
For more information on Cochlear Implant injuries, CLICK HERE.
