Mi1250 SYNCHRONY 2 PIN FLEXsoft 36677Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 09008737366773), received between Jan 11, 2021 and Apr 9, 2024 — classified as 5 injuries, 2 malfunctions.

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

• InjuryApr 9, 2024Microbial Contamination of Device; Microbial Contamination of Device

  DUE TO INFECTION THE DEVICE WAS EXPLANTED ON (B)(6) 2024. THE USER SUFFERED FROM OTITIS MEDIA WHICH SPREAD TO THE LEVEL OF THE IMPLANT. THE INFECTION HAS BEEN CONFIRMED BY CULTURES: STAPHYLOCOCCUS AUREUS. THE ISSUE STARTED 2,5 MONTHS PRIOR. AT THE EXPLANTATION SURGERY THE HOUSING WAS IN PLACE AND HEARING WAS NOT AFFECTED. RE-IMPLANTATION IS CONSIDERED AT A LATER TIME POINT.

  Patient problems: Bacterial Infection

  MAUDE report 19069150 ↗
• MalfunctionFeb 2, 2022Migration; Migration

  THE USER UNDERWENT A REPOSITIONING SURGERY AT THE BEGINNING OF (B)(6) 2022 DUE TO MOVEMENT OF THE IMPLANT TOWARDS THE PINNA. REPORTEDLY, THE USER THEN PUT ON HIS AUDIO PROCESSOR AND REPORTED A FUZZY SOUND QUALITY. A CT IS PLANNED TO CONFIRM THE PLACEMENT.

  Patient problems: Failure of Implant

  MAUDE report 13420777 ↗
• InjuryJun 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER SUFFERED FROM A PERSISTENT INFECTION OVER THE LEFT IMPLANT. LATER INCISION AND DRAINAGE WAS PERFORMED ON (B)(6) 2021 AND THE USER WAS TREATED WITH AUGMENTIN TO TREAT THE FLUID COLLECTION IN THE LEFT POSTAURICULAR AREA. PRELIMINARY LAB RESULTS OF CULTURED FLUID REVEALED (B)(6), AND THE CLINIC STARTED TREATMENT WITH BACTROBAN TOPICAL OINTMENT ON (B)(6) 2021. EXPLANTATION TOOK PLACE ON (B)(6) 2021. THE DEVICE HOUSING WAS FOUND IN PLACE AND ELECTRODE ARRAY FULLY INSERTED. THE PLAN WAS TO LEAVE THE ELECTRODE ARRAY IN THE COCHLEA AND LET THE INFECTION FULLY RESOLVE BEFORE REIMPLANTING A NEW DEVICE.

  Patient problems: Bacterial Infection

  MAUDE report 12064986 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE USER SUFFERED FROM A PERSISTENT INFECTION OVER THE LEFT IMPLANT. EXPLANTATION TOOK PLACE ON (B)(6) 2021. THE DEVICE HOUSING WAS FOUND IN PLACE AND ELECTRODE ARRAY FULLY INSERTED.

  Patient problems: Bacterial Infection

  MAUDE report 12047842 ↗
• InjuryFeb 10, 2021Migration; Migration

  THE RECIPIENT'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. IMAGING CONFIRMED THAT THE ELECTRODE ARRAY IS NOT COMPLETELY INSERTED IN THE COCHLEA. AT A REVISION SURGERY ON (B)(6) 2021 IT WAS CONFIRMED THAT THE ELECTRODE HAD BEEN PUSHED OUT DUE TO SOFT TISSUE, FIBROTIC GROWTH AND 2-3 CHANNELS WERE FOUND EXTRA-COCHLEAR. DESPITE EFFORTS THE ARRAY COULD NOT BE INSERTED ANY FURTHER AND THEREFORE IT WAS LEFT IN PLACE AT THE SAME INSERTION DEPTH.

  Patient problems: Failure of Implant

  MAUDE report 11307676 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE RECIPIENT'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. AT A REVISION SURGERY ON (B)(6) 2021 IT WAS CONFIRMED THAT ONLY 2-3- CONTACTS OF THE ELECTRODE WERE STILL INSIDE THE COCHLEA AND THE REST WERE EXTRA-COCHLEAR. ACCORDING TO THE SURGEON, THE ELECTRODE ARAY HAD BEEN PUSHED OUT BY OSSIFICATION AND FIBROTIC GROWTH. DESPITE EFFORTS THE ARRAY COULD NOT BE INSERTED ANY FURTHER AND THEREFORE IT WAS LEFT IN PLACE AT THE SAME INSERTION DEPTH. AFTERWARDS, THE USER COULD DETECT AUDITORY SENSATION ON 2 ACTIVE ELECTRODES. THE USER WAS RE-IMPLANTED WITH A COMPETITOR'S DEVICE ON (B)(6) 2021. AT RE-IMPLANTATION IT WAS CONFIRMED THAT OSSIFICATION AT THE BASAL TURN PUSHED THE ELECTRODE OUT OF THE COCHLEA.

  Patient problems: Extraskeletal ossification; Therapeutic Effects, Unexpected

  MAUDE report 11146800 ↗
• MalfunctionJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT HAS HAD A PERSISTENT, RE-OCCURRING INFECTION OVER THE LEFT IMPLANT WHICH LIMITED THE USE OF THE AUDIO PROCESSOR. THE RECIPIENT HAS CONTINUED ON MEDICAL MANAGEMENT AND HAS HAD NO FURTHER SWELLING AND NO FURTHER SURGERY. HE HAS BEEN WEARING THE DEVICE CONSISTENTLY SINCE (B)(6) 2020.

  Patient problems: Bacterial Infection

  MAUDE report 11145201 ↗

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-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
• 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