Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-2033-2020 · Posted None

Recalling FirmAdvanced Bionics, LLC
Recall StatusTerminated
Product CodeMCM
Date Initiated2020-02-17
Date Terminated2023-01-26
Product Quantity14068 units (CI-1600-04 = 9772 units and CI-1600-05 = 4296 units)

Reason for Recall

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

Firm Action

On 02/17/2020, the firm sent an "Urgent Field Action Notification" via email to healthcare providers informing them that the firm has detected an increase in the number of devices being explanted or the potential of being explanted due to performance issues (impedance drop and reports of hearing performance degradation) resulting from fluid ingress at the electrode. The Healthcare Notification instructs Healthcare Providers to: 1. Provide registration information for all devices that have been implanted; 2. Return any unimplanted devices and to emphasize not to implant any of these units. The Healthcare Provider Notification also provided the Healthcare Provider with a Patient Management information that includes "Key Clinical Questions". For questions, contact the Recalling Firm at: In the United States: (877) 8290026 between the hours of 5:00 AM and 5:00 PM Pacific Time, Monday through Friday. Europe / Asia Pacific / Latin America / Middle East and Africa: Please contact your local Advanced Bionics office with any questions. On 02/17/2020, the firm sent an "Important Notification" to implant receipients via FedEx to inform implant users or parents/caregivers of the issue of prolonged hearing degradation due to physiological fluid entering into the electrode (not the hermetic seal of the device body) and causing interruption of stimulation that can negatively affect device performance. The notification also informed users that the firm, as a precaution, is removing from the market all the initial version of unimplanted device and states that the performance degradation does not affect the safety of the device but revision surgery may be necessary due to the performance decrease. The firm is informing patients/users: -They should continue to use your device as normal. If you experience a decrease in hearing performance over time, you should visit your Audiologist to have your hearing assessed to understand if there could be a potential issue with yo

Root Cause

Device Design

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑