Mi1200 SYNCHRONY PIN +MEDIUM 09399Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09008737093990), received between Aug 11, 2021 and Jan 13, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (P000025); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2025Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  INFORMATION WAS RECEIVED THAT THIS USER HAS BEEN REIMPLANTED. ACCORDING TO NEW INFORMATION THE IMPLANT HOUSING DISLOCATED AND EXTRUDED THROUGH THE SKIN WITHOUT ANY TRAUMA, LIKELY DUE TO INTERFERENCE WITH GLASSES. WHILE THE SURGICAL INCISION LINE WAS OPEN, NO SIGNS OR CULTURE-CONFIRMED INFECTIONS WERE REPORTED. THE ISSUES BEGAN IN (B)(6) 2024.

  Patient problems: Insufficient Information; Skin Tears

  MAUDE report 21137618 ↗
• MalfunctionMay 10, 2023Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. REPORTEDLY, THERE HAS BEEN EXTRA-AUDITORY STIMULATION (NOTICED ON (B)(6) 2023) AND IMAGING REVEALED AN ELECTRODE ARRAY MIGRATION. DURING A REVISION SURGERY ON (B)(6)2023 THE ELECTRODE WAS REINSERTED INTO THE COCHLEA.

  Patient problems: Failure of Implant

  MAUDE report 16902354 ↗
• InjuryAug 11, 2021Malposition of Device; Malposition of Device

  DURING THE FIRST FITTING THE USER HAD NO SOUND SENSATION WITH THE DEVICE. FURTHERMORE, DIZZINESS AND LIGHTHEADEDNESS WERE OBSERVED AND THE USER NEEDED A WHEELCHAIR IN ORDER TO WALK. POST-OPERATIVE IMAGING SHOWED THAT THE ELECTRODE WAS INADVERTENTLY INSERTED INTO THE SEMICIRCULAR CANAL. THE USER WAS RE-IMPLANTED ON THE (B)(6)2021 AND HAS ALREADY BEEN ACTIVATED AND CAN HEAR WITH THE NEW DEVICE.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12306644 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000025. One submission often covers many models, so check the product and lot details in each record.

• Z-2356-2024 · Apr 18, 2024 · Open, Classified
  Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
• Z-2137-2019 · Oct 16, 2018 · Terminated
  MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard
• Z-2136-2019 · Oct 16, 2018 · Terminated
  MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi100
• Z-2138-2019 · Oct 16, 2018 · Terminated
  MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used toge