Mi1250 SYNCHRONY 2 FLEX20 37175Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09008737371753), received between Nov 18, 2020 and Nov 29, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FNS IS STILL PRESENT WITH THE NEW DEVICE. THE CLINIC IS PLANNING TO MONITOR IT THROUGH MAPPING IN THE FUTURE. IT WAS REPORTED THAT THE FACIAL NERVE WAS DAMAGED DURING DRILLING. THE USER WILL BE MONITORED TO SEE IF THE CONDITION IMPROVES.

  Patient problems: Twitching

  MAUDE report 18228838 ↗
• MalfunctionDec 9, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER WAS IMPLANTED IN (B)(6) 2022; HOWEVER, AROUND (B)(6) 2022 THE ELECTRODE BECAME EXPOSED IN THE EXTERNAL AUDITORY CANAL. THE USER WAS RE-IMPLANTED WITH A FORM19 ARRAY AND A FULL INSERTION WAS ACHIEVED. ONLY 3 ELECTRODES WERE INSIDE THE COCHLEA AT EXPLANTATION.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 15948426 ↗
• MalfunctionNov 22, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE USER HEARS A CLICKING, HIGH- AND LOW-PITCHED SOUND, WHEN PRESSING ON THE TRAGUS OR PUTTING THE AUDIO PROCESSOR ON. REPORTEDLY, PER INTERNAL SURGICAL REPORT, THERE WERE 4 CONTACTS LEFT OUTSIDE THE COCHLEA AT IMPLANTATION DUE TO THE VERY SMALL AND MALFORMED COCHLEA. THE USER HAS HAD A POOR HEARING PERFORMANCE WITH THE DEVICE SINCE ACTIVATION. THE USER HAS NOT BEEN SEEN FOR FOLLOW-UP THEREFORE NO NEW INFORMATION IS AVAILABLE.

  Patient problems: Dizziness; Failure of Implant; Insufficient Information

  MAUDE report 12850748 ↗
• InjuryNov 18, 2020Output Problem; Device Handling Problem; Output Problem; Device Handling Problem

  THE RECIPIENT WAS IMPLANTED WITH THE DEVICE ON THE (B)(6) 2020. IN SITU MEASUREMENTS PERFORMED A WEEK LATER SHOWED AFFECTED CHANNELS. THE RECIPIENT WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10859195 ↗

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-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