Z-2039-2009

Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. Cochlear...

Name: Z-2039-2009 Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. Cochlear...
Creator: Advanced Bionics LLC
Published: 2009-06-10
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2009-06-10 / Terminated / root cause: manufacturing process

FDA source

Advanced Bionics LLC began a recall of Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. Cochlear implant intended to restore a level of auditory... on 2009-06-10. The reason FDA records is "The recall was initiated after Advanced Bionics became aware of fourteen (14) devices manufactured between May 27, 2005 and June 30, 2005 that are confirmed to have or potentially have an issue related to the internal...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2039-2009
Status: Terminated
Initiated: 2009-06-10
Posted: 2009-09-11
Terminated: 2012-03-26
Recalling firm: Advanced Bionics LLC
Product: Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. Cochlear implant intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
Product code: MCM Implant, Cochlear
Reason for recall: The recall was initiated after Advanced Bionics became aware of fourteen (14) devices manufactured between May 27, 2005 and June 30, 2005 that are confirmed to have or potentially have an issue related to the internal magnet. These devices are were made with an internal magnet where the metal case surrounding the magnet was not properly welded. Patients with these devices may experience a decreas
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Advanced Bionics, LLC issued an "Important Notification" dated June 10, 2009 via Fed Ex to Consignees in the US and Canada. Outside of the US, the notification letters will be distributed in such a manner that delivery confirmation can be obtained. There were three type of notification letters distributed: one for Patients, one for Surgeons and one for Clinicians. Letters described the affected device prompting users on what to do next. An acknowledgement form was enclosed and should be completed and sent via fax to 1-661-362-7621. For further information, contact Advanced Bionics at 1-877-829-0026.
Quantity in commerce: 18
Distribution: Worldwide Distribution -- US, Canada, France and South Korea.
Product codes and lots: Serial Numbers: 225271, 301184, 225466, 225647, 225289, 225187, 300922, 225629, 225512, 301129, 300926, 225272, 225373, 300980, 225281, 225423, 225540 and 301027.

Product code MCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)