# FDA recall Z-2033-2020

> **Advanced Bionics, LLC** · Class II · device recall initiated 2020-02-17.

## 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 for recall

hearing performance degradation due to body-fluid entering the device.

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Canada, Brazil, Bangladesh, Switzerland, China, Australia, India, South Korea, Thailand, Ecuador, Mexico, El Salvador, Guatemala, Malaysia, Myanmar, Taiwan, Chile, Costa Rica, Colombia, Panama, Japan, Argentina, Peru, Singapore, China, New Zealand, Vietnam, Dominican Republic    Refer to uploaded consignee lists in Associated Documents:  Exhibit 05_ConsigneeList_Center_17FEB2020  Exhibit 06_ConsigneeList_Professionals_17FEB2020  Exhibit 07_ConsigneeList_Patients_17RFEB2020

## Key facts

- **Recall number:** Z-2033-2020
- **Recalling firm:** Advanced Bionics, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-17
- **Report date:** 2020-05-27
- **Termination date:** 2023-01-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Valencia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2033-2020

## Citation

> AI Analytics. FDA recall Z-2033-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2033-2020. Source: US FDA. Licensed CC0.

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