Mi1250 SYNCHRONY 2 FLEX34 S-Vector Magnet 41544Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09008737415440), received between Jul 28, 2026 and Aug 5, 2026 — classified as 3 injuries.

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

• InjuryAug 5, 2026Device Appears to Trigger Rejection

  There was reported skin flap breakdown 1 month post implantation. User was explanted.This report refers to 9710014-2026-00703. For further information please refer to this report.

  Patient problems: Tissue Breakdown

  MAUDE report 50139265 ↗
• InjuryJul 28, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  There was reported skin flap breakdown 1 month post implantation. User was explanted.

  Patient problems: Tissue Breakdown

  MAUDE report 50054489 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  The User reports just sounds like beeping and noise with the CI. Testing in the booth revealed poor pure tone thresholds and no speech understanding. User has significant facial twitching on many channels. There is lip twitching at levels that the user describes as soft. Deactivating them made no difference with the sound. Re-implantation done on (b)(6) 2026.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50052389 ↗

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