|Volume 6 Issue 269 Published - 14:00 UTC 08:00 EST 25-Sep-2004 Next Update - 14:00 UTC 08:00 EST 26-Sep-2004||Editor: Susan K. Boyer, RN
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Advanced Bionics conducts voluntary recall of cochlear implants
The Food and Drug Administration (FDA) announced today that Advanced Bionics Corporation, a wholly owned subsidiary of Boston Scientific Corporation, is conducting a voluntary recall of its un-implanted Clarion and HiResolution cochlear implants because some of the devices may malfunction due to moisture. The firm's recall will include notification to doctors and other healthcare professionals and patients.
Cochlear implants are intended to restore a level of auditory sensation to adults and children with severe-to-profound hearing loss via electrical stimulation of the auditory nerve.
Advanced Bionics has determined that device failure may occur due to moisture inside the product. Symptoms associated with device failure include, but are not limited to: 1) intermittent functioning; 2) sudden sensation of discomfort or pain; 3) sudden loud noise or popping sound; 4) complete loss of sound, and 5) unwillingness of a child to wear his or her external headpiece.
Patients who experience difficulties with these cochlear implants should try the backup cable, headpiece, and then the sound processor. If signs or symptoms persist, the headpiece should be removed and the user should contact his or her hearing care provider.
FDA is not recommending removal or replacement of any devices already implanted in patients.
Anyone with questions regarding the content of this recall, should contact Advanced Bionics at 1-877-454-5038, between the hours 5 AM and 5 PM Pacific Time, Monday through Friday. Also, FDA encourages users to report problems with these devices directly to MedWatch, FDA's voluntary reporting program. Reports may be submitted to MedWatch one of four ways: online at: https://www.accessdata.fda.gov/scripts/medwatch/ ; by telephone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; or by mail to MedWatch, Food and Drug Administration, HFD-410, 5600 Fishers Lane, Rockville, MD 20857.
Recall -- Firm Press Release
FOR IMMEDIATE RELEASE --Natick, MA (September 24, 2004) -- 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.
The signs and symptoms that a cochlear implant might be starting to fail include: a sudden sensation of discomfort or pain, a sudden loud noise or popping sound, an intermittent functioning, a complete loss of sound, and in a child, unwillingness to wear the external headpiece. If a user experiences any of these, he or she should try the backup cable, external headpiece, and then the sound processor. If signs or symptoms persist, the external headpiece should be removed and the user should contact his or her hearing care provider. Hearing clinics have a simple and quick way to test whether a cochlear implant is fully functional.
The products were distributed to hospitals and cochlear implant centers worldwide. Advanced Bionics is notifying the recipients via telephone, facsimile and mail.
Advanced Bionics is also sending letters to physicians and patients who are using these devices. In the United States, cochlear implant users have cards that identify the make and model of their device.
Clinician and patient inquiries may be directed to Advanced Bionics at 1-877-454-5038, between the hours of 5 AM and 5 PM Pacific Time, Monday through Friday.
Cochlear implants are devices used to treat the profoundly deaf. The technology consists of an external sound processor, which captures and processes sound information from the environment and transmits the digital information through the skin to the implant. The implant delivers digital pulses of electrical current to precise locations on the auditory nerve, which the brain perceives as sound.
Advanced Bionics generated revenues of $56 million in 2003.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com .
This press release contains forward-looking statements. The Company wishes to caution the reader that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with the regulatory process, litigation, competitive product offerings and other factors described in the Company's filings with the Securities and Exchange Commission.
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