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OPUS 2 Control Unit white, SP 36385

by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

OPUS 2 Control Unit white, SP 36385 is a Class III device made by Med-El Elektromedizinische Geräte Gesellschaft m.b.H., approved under FDA PMA P000025 on 20 Aug 2001 and listed in FDA GUDID since 10 Jul 2019 (UDI-DI 09008737363857), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P000025

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09008737363857 UDI-DI Date10 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR from GUDID Approved NumberP000025 Date20 Aug 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P000025 decided 20 Aug 2001 Active
  • FDA GUDID UDI-DI 09008737363857 listed 10 Jul 2019 Listed

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-2356-2024 FDA Class II initiated 18 Apr 2024

    A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.

  • 3 recalls, same reason

    • Terminated Z-2138-2019 FDA Class II initiated 16 Oct 2018 on shared PMA P000025
    • Terminated Z-2136-2019 FDA Class II initiated 16 Oct 2018 on shared PMA P000025
    • Terminated Z-2137-2019 FDA Class II initiated 16 Oct 2018 on shared PMA P000025

    Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

6 dated events

  1. Approved FDA PMA P000025
  2. Recall initiated FDA recalls Z-2138-2019
  3. Recall initiated FDA recalls Z-2136-2019
  4. Recall initiated FDA recalls Z-2137-2019
  5. Listed FDA GUDID 09008737363857
  6. Recall initiated FDA recalls Z-2356-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

GUDID

Trade name
OPUS 2 Control Unit white, SP
Generic name
Cochlear implant/auditory brainstem implant sound processor
Model / reference
36385
Primary DI / UDI-DI
09008737363857
PMA number
FDA product code
MCM
GMDN term
Cochlear implant/auditory brainstem implant sound processor
Device class
Class III
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Cochlear implant/auditory brainstem implant sound processor

Cleared under the same submission (P000025)

and 8 more cleared under P000025

Other devices from Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

See all devices from Med-El Elektromedizinische Geräte Gesellschaft m.b.H. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)