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U.S. Department of Health and Human Services

Class 2 Device Recall HiResolution" Bionic Ear System

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  Class 2 Device Recall HiResolution" Bionic Ear System see related information
Date Initiated by Firm February 17, 2020
Create Date May 15, 2020
Recall Status1 Open3, Classified
Recall Number Z-2033-2020
Recall Event ID 85141
PMA Number P960058 
Product Classification Implant, cochlear - Product Code MCM
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.
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.
Recalling Firm/
Manufacturer
Advanced Bionics, LLC
28515 Westinghouse Pl
Valencia CA 91355-1398
For Additional Information Contact
800-678-2575
Manufacturer Reason
for Recall
hearing performance degradation due to body-fluid entering the device.
FDA Determined
Cause 2
Device Design
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
Quantity in Commerce 14068 units (CI-1600-04 = 9772 units and CI-1600-05 = 4296 units)
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MCM and Original Applicant = ADVANCED BIONICS
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