CLASS II Device recall · Reported 31 Oct 2012 · FDA Enforcement Report
HiRes 90K devices with Helix Electrodes recalled by Advanced Bionics
Advanced Bionics is recalling HiRes 90K devices with Helix Electrodes, distributed nationwide in the US. The recall was initiated on 14 Sep 2007 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0117-2013
- FDA event ID
- 63353
- Recalling firm
- Advanced Bionics, Sylmar, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Sep 2007
- FDA classified
- 22 Oct 2012
- Reported
- 31 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 14 Sep 2007 | Recall initiated by company | |
| 22 Oct 2012 | Classified by FDA | +1865 days |
| 31 Oct 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution: USA (nationwide) including state: IL and country of: Europe.
Questions about this recall
Why was it recalled?
Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.
Which lots are affected?
Serial Numbers: 351323, 251153, 350989, 351226, 350196, 351136, 350140, 350201, 351261, 351264, 351266, 351269, 351412, 351415, 351429, 350157, 351303.
Where was it sold?
Worldwide distribution: USA (nationwide) including state: IL and country of: Europe.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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