AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ 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.
- Company
- Advanced Bionics, Llc
- Recall Initiated
- February 17, 2020
- Terminated
- January 26, 2023
- Recall Number
- Z-2032-2020
- Quantity
- 8159 units (CI-1601-04 = 3827 units and CI-1601-05 = 4332 units)
- Firm Location
- Valencia, CA
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
Lot / Code Info
Model Numbers: CI 1601 04 - HiRes Ultra 3D with HF Mid-Scala Electrode CI 1601 05 - HiRes Ultra 3D with HF SlimJ Electrode Lot Numbers - 1000000 thru 1999999.
Root Cause
Device Design
Action Taken
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