Boston Scientific Recalls Cochlear Implants Due to Moisture Issue

Strategic Insights -

Boston Scientific Corporation, following its acquisition of Advanced Bionics in June, has announced a voluntary worldwide recall of all unimplanted Clarion and HiResolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning. The company has estimated that approximately 440 devices have been shipped but not implanted, and is working with the U.S. Food and Drug Administration and notifying officials in other countries. The recall affects all unimplanted Clarion and HiResolution models.

Key Takeaways:

  • Boston Scientific is recalling all unimplanted Clarion and HiResolution cochlear implants due to potential moisture issues, which can cause the device to malfunction.
  • The recall applies to approximately 440 devices that have been shipped but not implanted.
  • The company is working with the U.S. Food and Drug Administration and notifying officials in other countries.
  • The signs and symptoms of a malfunctioning cochlear implant include sudden discomfort or pain, loud noise or popping sound, intermittent functioning, complete loss of sound, and in children, unwillingness to wear the external headpiece.
  • Users experiencing any of these symptoms should try the backup cable, external headpiece, and sound processor before removing the external headpiece and contacting their hearing care provider.
  • Hearing clinics have a simple and quick way to test whether a cochlear implant is fully functional.
  • Advanced Bionics is notifying the recipients of the recalled devices via telephone, facsimile, and mail, as well as sending letters to physicians and patients who are using these devices.

Statistics:

  • 440: The estimated number of devices shipped but not implanted.
  • Worldwide: The scope of the recall, affecting countries outside of the United States.
  • June: The month in which Boston Scientific acquired Advanced Bionics.

Sources:

  • Boston Scientific Corporation (Country of Origin Not Specified)
  • Advanced Bionics Corporation of Sylmar, California (USA)
  • U.S. Food and Drug Administration (USA)
  • NewsRx.com & NewsRx.net (General Health News Source)