Reported Oct 31, 2012 · Terminated
HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant…
Advanced Bionics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Bionics Corporation · 12740 San Fernando Rd · Sylmar, CA · 91342
Is this the product you have?
- HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal components include a stimulator (HiRes90K ICS) and electrode array (HiFocus 1j or Helix). The HiRes90K ICS is implanted surgically under the skin behind the ear. The electrode array is inserted into the cochlea. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. The Helix consists of a fantail, electrode lead, and Helix electrode array. The electrode, comprised of platinum-iridium wires, is housed in a silicone carrier and extends from the titanium case. The Helix electrode array is 24.5 mm in length and is designed to be inserted approximately 18-21 mm into a normal patent cochlea. It consists of 16 planar contacts arranged along the medial surface of the electrode array for stimulation of discrete segments of the cochlea. The Helix electrode insertion tool is designed to assist the surgeon with the insertion of the Helix electrode. Only the Helix insertion should be used for insertion of the Helix electrode; the use of other instruments may result in damage to the electrode. The insertion tool is a single-use instrument.
- Lot codes and dates
- Serial Numbers
351323251153350989351226350196351136350140350201351261351264351266351269351412351415351429350157351303
- Serial Numbers
- Amount recalled
- 17 units
Where it was sold
- Nationwide
- IL
Why it was recalled
Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.
This product could cause temporary or reversible health problems — stop using it.
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