Z-1259-2020Class III

HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant

Name: Z-1259-2020 HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant
Creator: Advanced Bionics, LLC
Published: 2019-03-18
License: https://open.fda.gov/license/

Advanced Bionics LLC / initiated 2019-03-18 / Terminated

FDA source

Advanced Bionics, LLC began a recall of HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant on 2019-03-18. FDA classified it as Class III and gives the reason as "Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1259-2020
Classification: Class III
Status: Terminated
Initiated: 2019-03-18
Posted: 2020-02-18
Terminated: 2021-04-27
Recalling firm: Advanced Bionics LLC
Product: HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Product code: MCM Implant, Cochlear
Reason for recall: Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
FDA root cause: Other
Action: On March 18, 2019, the firm sent a "Voluntary Field Action" letter was sent to Japanese surgeons who implanted the device. The firm has stopped sales until the documentation is finalized. The field action letter informed customers that the action was due to an error in documentation and poses no risk to patient safety. The serial numbers of implanted HiRes90K Advantage cochlear implants with 1J and MS electrodes will be made available on the PMDA website.
Quantity in commerce: 4
Distribution: No US distribution OUS: Japan
Product codes and lots: All Lots, UDI (01)07630016832185 Not distributed within the US

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1259-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1259-2020	Class III	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-18

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)