Reported May 27, 2020 · Terminated
AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a…
Advanced Bionics, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Advanced Bionics, LLC · 28515 Westinghouse Pl · Valencia, CA · 91355-1398
Is this the product you have?
- AB HiResolution Bionic Ear System, HiRes Ultra CI
- MS Electrode - Product UsageThe device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve
- Lot codes and dates
- Model NumbersCI 1600 04 - HiRes Ultra with HF Mid-Scala Electrode CI 1600 05 - HiRes Ultra with HF Mid-Scala Electrode Lot Numbers - 1000000 thru 1999999
- Amount recalled
- 14068 units (CI-1600-04 = 9772 units and CI-1600-05 = 4296 units)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
hearing performance degradation due to body-fluid entering the device.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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