News: cochlear implants recall

Nancy

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Boston Scientific Recalls Ear Implant

Boston Scientific Recalls Ear Implant

URL: http://story.news.yahoo.com/news?tmpl=stor...onscientific_dc

CHICAGO (Reuters) - Boston Scientific Corp (NYSE:BSX - news) said on Friday it has recalled an ear implant the company acquired as part of its purchase of Advanced Bionics in June.

Boston Scientific, which was hit this summer with a much larger recall of its drug-coated stents, said it was recalling about 440 Clarion and HiResolution cochlear implants because they may have contained moisture in the internal circuitry, which could cause them to fail.

Natick, Massachusetts-based Boston Scientific said the recall does not affect patients who already have been implanted with the device and said it is not aware of any patient injuries.

The company said it is working with the U.S. Food and Drug Administration (news - web sites) and notifying regulators from other countries.

The FDA (news - web sites), in a separate statement, said signs of device failure include sudden loud noises or a popping sound, unreliable service or a complete loss of sound. The agency said if symptoms persist, patients should contact the manufacturer.

The products were distributed to hospitals and cochlear implant centers worldwide. The devices are used to treat deafness.

Shares of Boston Scientific were up 49 cents, or 1.3 percent, at $38.28 in Friday afternoon trade on the New York Stock Exchange (news - web sites).
 
WASHINGTON There's a recall involving devices used to help people hear.
Advanced Bionics Corporation says its CLARION and HiResolution cochlear implants can malfunction if moisture reaches the circuitry.

It's issuing a worldwide recall of devices that have not yet been implanted.

The recall doesn't apply to the 25-hundred of the devices that already have been implanted in patients' ears. But the company is urging people who use them to contact their doctor if they suspect a problem. Malfunctioning devices may require replacement.

Cochlear implants send digital pulses that the brain interprets as sound. Faulty devices can produce a loud noise or pop, cause sudden pain, lose function intermittently or stop producing sound entirely.

There are no reports of any injuries.

http://www.wfsb.com/Global/story.asp?S=2346437
 
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Hmm...I don't have the Clarion -- so I'm not worried. :) Just hope that those reciepients are rectified with a replacement and the sorts.
 
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