Cochlear recalling unimplanted Nucleus CI500 devices because of failure risk

SYDNEY, AUSTRALIA–Cochlear Limited, the world’s dominant manufacturer of cochlear implants, announced today (September 12) that it is voluntarily recalling unimplanted devices in the Nucleus CI500 range after learning of an increased incidence of failures in its Nucleus CI512 implants.

According to the Australian-based company, fewer than 1% of the CI512s implanted since the product’s introduction in 2009 have failed. However, the company explained in a statement released Monday, “In an abundance of caution, Cochlear has issued a voluntary recall of the Nucleus CI500 range of cochlear implants while it further investigates the cause of this issue.” Cochlear said that when device failure occurs, the implant shuts down, but without causing any injury to the user.

People whose implanted Nucleus CI502 devices fail can have them re-implanted with the Nucleus Freedom implant range, which remains available. Patients whose implants are performing properly can continue to wear them.

The Nucleus CI500 implant range includes the Nucleus CI512, Nucleus CI513, Nucleus CI551 double-array implant, and Nucleus ABI 541 Auditory Brainstem Implant.

 

STOCK MARKET RESPONDS

Cochlear’s announcement led to an immediate sharp drop in the price of its stock, which is traded on the Australian Exchange. Following today’s news, Cochlear stock plummeted by 20% to A$57.77, a loss of A$820 million in the company’s total market value.

Cochlear said the longer-term financial impact of the recall was difficult to predict.

Founded in 1981, Cochlear Ltd. designs, manufactures, and sells the Nucleus Cochlear implant worldwide. An estimated 250,000 people use its implants.

This is not the first recall of cochlear implants. In 2002, Advanced Bionics recalled its Clarion model after the U.S. Food and Drug Administration (FDA) issued a warning that cochlear implants were associated with meningitis. That company also recalled products in 2004 and 2006 because of a potential moisture failure within the implant.