Advanced Bionics, LLC: Medical Device Recall in 2020 - (Recall #: Z-2033-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 17, 2020

Date Posted: May 27, 2020

Recall Number: Z-2033-2020

Event ID: 85141

Reason for Recall:

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

Status: Terminated

Product Quantity: 14068 units (CI-1600-04 = 9772 units and CI-1600-05 = 4296 units)

Code Information:

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.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated