FDA Device recall Z-2033-2020
AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sens…
- FDA Device
- Class II
- terminated
- Published 2020-05-27
On 2020-05-27 the FDA classified a Class II recall of AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sens… by Advanced Bionics, citing hearing performance degradation due to body-fluid entering the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2033-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-17 |
| Published | 2020-05-27 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Advanced Bionics |
| Distribution | US |
Product
AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
Reason
hearing performance degradation due to body-fluid entering the device.
Identifiers
| code_info | Model Numbers: CI 1600 04 - HiRes Ultra with HF Mid-Scala Electrode CI 1600 05 - HiRes Ultra with HF Mid-Scala Electr…Model Numbers: CI 1600 04 - HiRes Ultra with HF Mid-Scala Electrode CI 1600 05 - HiRes Ultra with HF Mid-Scala Electrode Lot Numbers - 1000000 thru 1999999. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2033-2020%22
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