Australia's bionic ear maker Cochlear is undertaking a global recall of the unimplanted Nucleus CI500 cochlear implant range after some stopped working, the company said on Monday.
Cochlear has identified a recent increase in the number of Nucleus CI512 implant failures and issued a voluntary recall of the Nucleus C1500 range of cochlea implants while it further investigates the cause of the problem, the Sydney-based company said.
While Cochlear believes the faults are unlikely to cause any health problems for people with defective implants, they are offering replacement models for re-implantation.
The news sent Cochlear's shares into a tailspin, with the stock dropping over 20 percent on Monday amid worries about the financial impact and potential damage to the company's reputation the recall could cause.
Cochlear Chief Executive Chris Roberts said he was unable to say how many of the "very reliable" titanium-based devices were faulty.
All existing recipients with a Nucleus CI500 series implant but who have not experienced any problems can continue to use their system as normal, the company said.
The recall of the Nucleus CI500 range includes the CI512 model as well as the CI513, CI551 double array implant and Nucleus ABI 541 Auditory Brainstem Implant.
It does not affect its earlier Nucleus Freedom range or its Nucleus 5 external hearing devices.
Production of the CI500 devices has stopped and patients needing bionic ear implants are being offered the Nucleus Freedom model, which has been on the market for seven years.
The company said the financial impact of this recall was difficult to predict at this stage.
