Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 31, 2012
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
Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Advanced Bionics Corporation recalled HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear … - a moderate-severity action.
HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear … was recalled by Advanced Bionics Corporation in October 31, 2012. Reason: Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loos…. Check the official notice for the remedy. Verify recall #Z-0117-2013 with the FDA Devices before acting.
The recall
Advanced Bionics Corporation issued this moderate-severity FDA Devices recall-Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loos….
- Moderate
- severity level
- 17 units
- affected scope
- Class II
- classification
- October 31, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0117-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0117-2013) was formally reported on October 31, 2012, with the manufacturer initiating the action on September 14, 2007. It is classified under Moderate severity (Class II), with a current status of Terminated. Advanced Bionics Corporation is listed as the recalling firm, operating out of Sylmar, CA. Federal records list the affected scope as 17 units.
The documented reason for this recall is: Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies. Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) including state: IL and country of: Europe.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
17 units
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0117-2013 |
| Date reported | October 31, 2012 |
| Date initiated | September 14, 2007 |
| Recalling firm | Advanced Bionics Corporation |
| Firm location | Sylmar, CA |
| Affected scope | 17 units |
| Distribution | Worldwide distribution: USA (nationwide) including state: IL and country of: Europe. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0117-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Advanced Bionics Corporation. Units affected: 17 units.
Why was this product recalled? ▼
Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2012. Severity: Moderate. Recall number: Z-0117-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (nationwide) including state: IL and country of: Europe..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0117-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 31, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.