Mi1250 SYNCHRONY 2 STANDARD 36672Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 09008737366728), received between Jul 31, 2020 and Feb 20, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Output Problem” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE MAGNET HAS BEEN SURGICALLY REPLACED. REPORTEDLY, THE REASON WAS RETENTION ISSUES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21418967 ↗
• MalfunctionJan 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE CLINIC IS PLANNING TO EXCHANGE THE IMPLANT MAGNET. NO SURGERY DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21194780 ↗
• InjuryJul 21, 2021Output Problem; Device Handling Problem; Output Problem; Device Handling Problem

  THE USER HAD POOR HEARING PERFORMANCE WITH THE DEVICE, WITH A SLOW CHANGE IN HEARING WITH THE DEVICE OVER TIME. THE USER WAS RE-IMPLANTED. THE USER'S HEARING PERFORMANCE WITH THE NEW DEVICE IS GOOD.

  Patient problems: Failure of Implant

  MAUDE report 12201308 ↗
• InjuryMar 9, 2021Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.

  Patient problems: Failure of Implant

  MAUDE report 11443014 ↗
• InjuryFeb 15, 2021Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. AROUND 6 MONTHS AFTER IMPLANTATION A CT SCAN SHOWED THAT 4/5 CHANNELS WERE OUT OF THE COCHLEA. AT THE REVISION SURGERY TO REINSERT THE ARRAY SEVERAL CONTACTS OF THE ELECTRODE WERE DAMAGED BY THE SURGICAL INSTRUMENTS (MED-EL CLAW _ FENTEX) WHILE TRYING TO REINSERT THE ARRAY. THEREFORE, THE RECIPIENT WAS RE-IMPLANTED WITH THE BACK-UP DEVICE. THE ARRAY WAS FULLY INSERTED.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 11327347 ↗
• InjuryNov 23, 2020Output Problem; Output Problem

  AFFECTED CHANNELS HAVE BEEN OBSERVED DURING IN SITU TESTING. AT A VISIT ON THE 18TH FEBRUARY THE USER REPORTED AN OFF-SENSATION OF HEAD FEELING SOFT AND DIZZINESS WHEN WEARING THE DEVICE. HOWEVER, ON THE (B)(6) 2020 THE USER REPORTED THAT THE HEARING WAS IMPROVING AND THE SOFT FEELING AND DIZZINESS HAD GONE. HOWEVER, LOUD VOICES WERE UNCOMFORTABLE WHEN NEAR THE IMPLANTED SIDE. THE USER WAS RE-IMPLANTED ON THE (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 10883206 ↗
• InjuryJul 31, 2020Output Problem; Output Problem

  LOUD VOICES ARE UNCOMFORTABLE WHEN THEY ARE NEAR THE IMPLANTED SIDE.

  Patient problems: Failure of Implant

  MAUDE report 10349056 ↗

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-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
• 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-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