Image via CrunchBaseAdvanced Bionic has advanced a recall of its cochlear implant systems, announced today that it has notified the US Food & Drug Administration (FDA) that it will voluntarily recall its HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution. This action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation.These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.
There are three companies in the world that manufacture cochlear implants: Med-El, Cochlear Corporation, and Advanced Bionics. Advanced Bionics is based in the Los Angeles, California area, and Advanced Bionics was recently acquired by Sonova, a Swiss corporation. Advanced Bionics was previously controlled and owned by Boston Scientific Corporation. Over the course of its history, Advanced Bionics has manufactured three types of cochlear implants: (1) The Clarion / Clarion 1.2 / C1.2, (2) The Clarion II / CII, and (3) The HiResolution 90k / HiRes90k.
In 2004, Advanced Bionics issued a worldwide recall of all unimplanted Clarion and HiRes90k devices. The company was issued a Warning Letter by the United States Food and Drug Administration (FDA) in February 2005. Later, in March 2006, the company issued a second recall of all unimplanted HiRes90k devices containing a feedthrough manufactured by AstroSeal, Inc. / vendor B. Almost 4,500 persons around the world were implanted with HiRes90k with vendor B feedthrough components.
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