Boston Scientific Recalls Ear Implant

From: Boston.com, MA - Sep 24, 2004

CHICAGO (Reuters) - Boston Scientific Corp (BSX.N) 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 and notifying regulators from other countries.

The FDA, 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.

© Copyright 2004 Reuters.