Advanced Bionics HiRes90k Recall
Call (866) 884-1717 to Reach a Defective Product Lawyer
At Shoop | A Professional Law Corporation, our attorneys have 35+ years of combined experience, earned recognitions such as inclusion in Super Lawyers®, and recovered multi-million dollar verdicts and settlements.
Our Los Angeles product liability attorneys represent cochlear implant victims nationally. In our representing Advanced Bionics clients, we have gained invaluable insight into how to handle these cases efficiently. Our team continues to represent victims of failed cochlear implants, including certain of the Advanced Bionics HiResolution 90k (HiRes90k) and Clarion implant model, based on failures in the manufacturing process and numerous FDA violations.
If you or your child has suffered from a defective cochlear implant, you can schedule your FREE consultation today! We will strive to resolve your Advanced Bionic claim as quickly as possible.
The product defect associated with these HiRes90k devices in question relate to a defective, internal component of the cochlear implant (CI) device called a "feedthru" (or "feed-through") manufactured by a California corporation called, "Astro Seal" (at times, Astro Seal was referenced within various Advanced Bionics notification letters to their CI recipients as "Vendor B"). The feedthru unit is the part of the implanted internal component which conducts the electrical signals from the implanted portion of the electrode array within the cochlear nerve.
You may have received either September 2004 or March 2006 "Notification" letters from Advanced Bionics warning of a failed hermetic seal and moisture-related issues within their cochlear implants. Advanced Bionics has additionally provided a list of potential symptoms for this product failure mode.
Complaints Involved in the HiRes90k Recall
Advanced Bionics has been accused of breaking federal law, specifically, of violating the FDA's manufacturing guidelines. In 2006 and into 2007, the FDA filed and amended a complaint against Advanced Bionics under the medical device regulations of the FDCA (Food, Drug and Cosmetic Act).
These FDA complaints alleged that Advanced Bionics:
- Violated cGMP (Current Good Manufacturing Practice)
- Failed to seek PMA (Premarket Approval)
- Failed to give a 30-day notice before utilizing the Astro Seal feedthru
The FDA alleged that the design criteria and specifications of the Astro Seal feedthru components were different from the specifications of the feedthru submitted to the FDA for approval, thus rendering the device "adulterated" and in violation of federal law. On July 7, 2008, the FDA and the Advanced Bionics settled an Administrative Action, with Advanced Bionics agreeing to pay in a more than one million dollar fine.
Team Up with Us for Your Product Liability Case
Shoop | A Professional Law Corporation additionally represents numerous children and adults implanted with the defective Cochlear Nucleus CI512 device. You can read additional information regarding the Cochlear Nucleus recall here.
Our firm recommends that cochlear implant victims and parents of minor victims not release any of their rights to recovery for injuries sustained and financial losses, not without first consulting an attorney who has substantial experience investigating defective products, and litigating cases involving defective medical devices.
If you or a family member has suffered a failure of the Advanced Bionics HiResolution 90k (HiRes90k) or the Cochlear Ltd., CI500 series implant, contact us today to speak with an experienced attorney about your legal options.
Call (866) 884-1717 right away to set up a free consultation regarding your case.