Mi1260 SONATA 2 STANDARD 38538Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 09008737385385), received between Mar 24, 2022 and Sep 16, 2026 — classified as 21 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (32 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 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Explantation due to an infection.

  Patient problems: Unspecified Infection

  MAUDE report 50785777 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Explantation due to an infection.

  Patient problems: Unspecified Infection

  MAUDE report 50785775 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  The child had very high fever, was hospitalized for a couple of days and was diagnosed with meningitis. Prior the event the user was hearing fine, afterwards stopped hearing. After waiting for improvement, the user was re-implanted on (b)(6) 2026.

  Patient problems: Meningitis

  MAUDE report 50006202 ↗
• MalfunctionJul 16, 2026Impedance Problem

  Device malfunction.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25836923 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  THE IMPLANT HAD TO BE REMOVED BECAUSE THE OF A POSITIVE CULTURE AT THE IMPLANT SITE.

  Patient problems: Medical device site infection

  MAUDE report 25689004 ↗
• MalfunctionJun 18, 2026Impedance Problem

  THE HEARING WITH THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25542182 ↗
• MalfunctionMay 27, 2026Circuit Failure

  THE HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED IN THE ABSENCE OF ANY TRAUMA OR ACCIDENT. THE USER WAS REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25297565 ↗
• MalfunctionApr 24, 2026Impedance Problem

  THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24977966 ↗
• InjuryApr 16, 2026Device Appears to Trigger Rejection

  THE DEVICE WAS EXPLANTED.

  Patient problems: Tissue Breakdown

  MAUDE report 24896039 ↗
• InjuryApr 13, 2026Device Appears to Trigger Rejection

  DEVICE WAS EXPLANTED DUE TO THE EXTRUSION OF THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24857588 ↗
• MalfunctionApr 13, 2026Impedance Problem

  THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.

  Patient problems: Insufficient Information

  MAUDE report 24856926 ↗
• MalfunctionMar 12, 2026Migration

  A DAY AFTER REIMPLANTATION, AN X-RAY REVEALED THAT THE ELECTRODES WERE OUTSIDE THE COCHLEA. THE USER WAS REIMPLANTED AGAIN.

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

  MAUDE report 24577705 ↗
• MalfunctionMar 12, 2026Circuit Failure

  ONE MONTH AFTER THE FIRST IMPLANTATION (SN (B)(6)), THEY CAME FOR FIRST FITTING AND THE IMPLANT DID NOT CONNECT, THE REASON IS UNKNOWN. THE USER WAS REIMPLANTED.

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

  MAUDE report 24577704 ↗
• MalfunctionMar 10, 2026Insufficient Device Problem Information

  THE DEVICE WAS EXPLANTED. THE REASON FOR RE-IMPLANTATION IS AN INJURY IN (B)(6) 2026, AFTER WHICH THE USER SUDDENLY LOST HER HEARING.

  Patient problems: Head Injury; Insufficient Information

  MAUDE report 24555112 ↗
• MalfunctionMar 5, 2026Impedance Problem

  HEARING PERFORMANCE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516875 ↗
• InjuryFeb 27, 2026Device Appears to Trigger Rejection

  IN (B)(6) OF 2024, THREE WEEKS AFTER ACTIVATION, THE WOUND BEGAN TO BREAK DOWN, RESULTING IN PARTIAL IMPLANT EXPOSURE. UNDER GENERAL ANESTHESIA, THE WOUND WAS CLEANED, RE_EXPLORED, AND A TEMPOROPARIETAL FASCIA (TPF) FLAP WAS PERFORMED. IN (B)(6) 2025, THE USER PRESENTED WITH SWELLING. THE USER DECLINED ASPIRATION OF THE FLUID PROCEDURE AND USER WAS THEN LOST TO FOLLOW_UP FOR FOUR MONTHS. THE USER RETURNED IN (B)(6) 2025 WITH DISCHARGE FROM A PARTIALLY DEHISCENT WOUND. A PUS SAMPLE FOR CULTURE AND SENSITIVITY WAS COLLECTED. THE WOUND WAS IRRIGATED WITH SALINE AND ANTIBIOTICS AND SUBSEQUENTLY SUTURED. THIS PROCEDURE WAS PERFORMED TWICE.

  Patient problems: Tissue Breakdown

  MAUDE report 24468276 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE USER WAS EXPLANTED DUE TO INFECTION. THE SKIN OVER THE IMPLANT WAS NOT INTACT BEFORE DEVICE REMOVAL AND REPORTEDLY, THERE WAS GRANULATION TISSUE.

  Patient problems: Bacterial Infection

  MAUDE report 24386727 ↗
• MalfunctionFeb 5, 2026Circuit Failure

  THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267459 ↗
• MalfunctionJan 28, 2026Device Damaged Prior to Use

  DURING SURGERY FOR A BILATERAL COCHLEAR IMPLANTATION CASE, THE SURGEON OPENED AN INTACT, SEALED MED-EL COCHLEAR IMPLANT INTENDED FOR INSERTION IN THE LEFT EAR. PRIOR TO HANDING OVER THE IMPLANT TO THE SURGEON THE AUDIOLOGY TEAM PERFORMED IN-PACKAGE TELEMETRY AS PER STANDARD PROTOCOL. AT THAT TIME, THE IN PACKAGE TELEMETRY RESULTS WERE COMPLETELY NORMAL, AND NO ABNORMALITY WAS DETECTED. HOWEVER, UPON OPENING THE IMPLANT BOX IN THE OT AND WHILE PREPARING THE DEVICE FOR SURGICAL INSERTION, IT WAS OBSERVED THAT THE INTERNAL MAGNET WAS LOOSE AND BECAME AUTOMATICALLY EXPELLED FROM ITS HOUSING WITHOUT ANY MANUAL FORCE OR MANIPULATION. THE IMPLANT HAD NOT YET BEEN HANDLED FOR PLACEMENT. IMMEDIATELY AFTER IDENTIFYING THE ISSUE, THE IMPLANT WAS NOT USED. THE DEVICE WAS CAREFULLY KEPT IN ITS ORIGINAL BOX IN THE SAME CONDITION AS OBSERVED. TO PROCEED WITH THE SURGERY AND ENSURE USER SAFETY, THE ALTERNATE IMPLANT THAT WAS ORIGINALLY PLANNED FOR THE CONTRALATERAL EAR WAS USED INSTEAD. NO ATTEMPT WAS MADE TO REINSERT OR MANIPULATE THE EXPELLED MAGNET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200676 ↗
• InjuryJan 28, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  In (b)(6)2025 parents noticed discharge from the incision site. They contacted the surgeon and the wound was managed immediately with IV and oral antibiotics. After four weeks of extensive treatment no improvement was noticed and implant was fully exposed. To prevent further spread of infection, the device was explanted in (b)(6)2026.

  Patient problems: Post Operative Wound Infection; Tissue Breakdown

  MAUDE report 24200666 ↗
• InjuryJan 28, 2026Malposition of Device; Adverse Event Without Identified Device or Use Problem

  USER DEVELOPED MENINGITIS ON THE SECOND POST-OP DAY DUE TO CSF LEAK. DECISION WAS TAKEN TO EXPLANT THE DEVICE. THE USER WILL RECEIVE A NEW CI.

  Patient problems: Meningitis

  MAUDE report 24197499 ↗
• MalfunctionJan 28, 2026Impedance Problem

  THE USER REPORTS AFFECTED SPEECH PERCEPTION.

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

  MAUDE report 24197496 ↗
• InjuryDec 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  URGENT EXPLANTATION IS SCHEDULED DUE TO EXTRUSION AND INFECTION WHICH STARTED ON 07-MAY-2025. THE DEVICE IS EXTRUDING THROUGH THE SURGICAL LINE. THE SURGICAL WOUND DID NOT HEAL FULLY. RECURRENT INFECTION AND DELAYED WOUND HEALING WERE OBSERVED BEFORE THE EXTRUSION OCCURRED. THE SURGEON PERFORMED LOCAL DRESSING TWICE AND PRESCRIBED ANTIBIOTIC THERAPY, BUT THE INFECTION DID NOT IMPROVE. THE PATIENT REQUIRED HOSPITAL-BASED MANAGEMENT DUE TO THE PERSISTENT INFECTION AND FINALLY THE DEVICE WAS EXPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 23765736 ↗
• MalfunctionNov 24, 2025Impedance Problem; Impedance Problem

  IN SITU TESTING SHOWED AFFECTED CHANNELS. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Head Injury

  MAUDE report 23630201 ↗
• MalfunctionNov 21, 2025Impedance Problem; Impedance Problem

  THE USER HAS NO SOUND PERCEPTION WITH THE INTERNAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23614702 ↗

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