Mi1260 SONATA 2 FLEX28 38545Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 09008737385453), received between Aug 30, 2021 and Sep 25, 2026 — classified as 33 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (22 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 73 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Device Appears to Trigger Rejection

  The user suffers from an implant extruding through the skin. As per new information received, the issue started on August 5th; implant telemetry showed the electrodes were functioning correctly, but calibration was not possible because the processors were broken. No skin damage was observed at that time. On August 25th, the mother reported the wound at the implant site. The mother did report to the audiologist that the child had become more aggressive since he stopped using the processors. The devices were sent for technical inspection, and a failure in the RCB was found in both units.

  Patient problems: Tissue Breakdown

  MAUDE report 50895292 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  Explantation due to an infection.

  Patient problems: Unspecified Infection

  MAUDE report 50785774 ↗
• InjurySep 11, 2026Insufficient Device Problem Information

  Following implantation on (b)(6) 2025 the patient developed a persistent infection at the implant site. Despite appropriate medical management and treatment, the infection did not resolve.Due to the non-resolving infection, the decision was made to explant the device on (b)(6) 2026 to ensure patient safety and prevent further complications.

  Patient problems: Unspecified Infection

  MAUDE report 50728507 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  The user's mother reported swelling and fluid/pus discharge at the implant site. Initially, signs were consistent with infection, with no evidence of extrusion.In (b)(6)2026, it was reported that the internal component had become visible. According to the images sent, the implant has extruded through the skin. As per new information received, the patient's condition began in mid-2025, with the appearance of a small pustule in the right mastoid region and occasional right-sided otorrhea. The treating ENT performed drainage and prescribed antibiotics.In (b)(6) 2025, in situ measurements were within normal limits. During the same month, recurrent signs of right-sided mastoiditis occurred. A CT scan shows opacification of the right mastoid with isodense material and adequate positioning of the cochlear implant. As an incidental finding, a cyst was observed in the right temporal region, with displacement of the structures toward the midline. A culture of the drainage showed growth of S. aureus and S. pneumoniae, both susceptible to levofloxacin and ceftriaxone.The patient was hospitalized at the end of (b)(6) 2025 and underwent surgery on (b)(6) 2025, for drainage and cleaning of the ma

  Patient problems: Skin Infection

  MAUDE report 50685535 ↗
• MalfunctionSep 8, 2026Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670086 ↗
• MalfunctionJul 17, 2026Impedance Problem

  DEVICE MALFUNCTION. NO TRAUMA HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25852872 ↗
• MalfunctionJul 2, 2026Impedance Problem

  Implantation was performed in (b)(6)2026. The standard procedure was followed, with in-situ testing of the device carried out before implantation. The device was found to be within normal parameters. The active electrode was inserted atraumatically. However, when the Intraoperative Functional Test (IFT) was performed, high impedances ranging from 12 to 17 k_ were detected. The device was removed and reinserted, but the results were the same. The backup device was implanted during the same surgical procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688998 ↗
• InjuryMay 19, 2026Device Appears to Trigger Rejection; Insufficient Device Problem Information

  THE USER EXPERIENCED AN INFECTION THAT HAS REACHED THE RECEPTOR/STIMULATOR AND THE ELECTRODE IS EXTRUDING. EXPLANTATION SCHEDULED FOR (B)(6) 2026.

  Patient problems: Unspecified Infection

  MAUDE report 25216734 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS EXPLANTED DUE TO INFLAMMATION.

  Patient problems: Inflammation

  MAUDE report 25108962 ↗
• InjuryMay 5, 2026Device Appears to Trigger Rejection

  THE USER SUSTAINED TRAUMA TO THE IMPLANT SITE, FOLLOWED BY PROGRESSIVE SWELLING AND INFLAMMATION. DESPITE PROLONGED CONSERVATIVE MANAGEMENT WITH ORAL ANTIBIOTICS FOR TWO MONTHS, THE CONDITION DETERIORATED, LEADING TO SKIN BREAKDOWN OVER THE IMPLANT SITE WITH DEVICE EXPOSURE, GRANULATION TISSUE FORMATION, AND A SIGNIFICANT SOFT TISSUE DEFECT. THE USER WAS SUBSEQUENTLY ADMITTED AND TREATED WITH INTRAVENOUS ANTIBIOTICS. HOWEVER, FOLLOWING MULTIDISCIPLINARY EVALUATION (ENT, COCHLEAR IMPLANT SURGEON, AND PLASTIC SURGERY TEAM), IT WAS CONCLUDED THAT SALVAGE OF THE IMPLANT WAS NOT FEASIBLE. EXPLANTATION WAS PERFORMED WITH A PLAN FOR SOFT TISSUE RECONSTRUCTION AND INFECTION CONTROL. GIVEN THE CURRENT LIMITATIONS IN HEALTHCARE RESOURCES AND THE USER_S LIVING CONDITIONS, NO FURTHER CONSERVATIVE OR SURGICAL SALVAGE OPTIONS WERE VIABLE.

  Patient problems: Head Injury

  MAUDE report 25078338 ↗
• InjuryMar 12, 2026Device Appears to Trigger Rejection

  HER CONDITION SEEMED TO BE STABLE UNTIL THE DOCTOR GOT A PHOTO OF THE IMPLANT SITE SHOWING THAT THE IMPLANT (THE TITANIUM STIMULATOR) WAS EXPOSED ON (B)(6) 2026. ON (B)(6) 2026 PLASTIC SURGEON IS SEEING THE USER ABOUT PERFORMING A SKIN FLAP SURGERY . THE TEAM IS HOPING THAT THIS WILL NOT RESULT IN AN EXPLANT HOWEVER THE POSSIBILITY CANNOT BE RULED OUT.

  Patient problems: Bacterial Infection

  MAUDE report 24577537 ↗
• MalfunctionFeb 4, 2026Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE HAS DECREASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24256827 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ABOUT 5-6 MONTHS AFTER THE SURGERY, AN INFECTION DEVELOPED IN THE IMPLANT AREA. ONCE THE INFECTION AND SKIN HAVE COMPLETELY HEALED, THE USER WILL BE REIMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 23863440 ↗
• MalfunctionDec 19, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  THE DEVICE WAS NOT USED, AS IT WAS NOTICED THAT ONE PART OF THE COIL WIRE WAS COMING OUT OF THE SILICONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849281 ↗
• MalfunctionDec 16, 2025Impedance Problem; Device Handling Problem; Impedance Problem; Device Handling Problem

  AT THE SURGERY ON (B)(6) 2025 THE SURGEON HAD TO MANIPULATE THE TIP OF THE ELECTRODE LEAD A LITTE (IT WAS A BIT TILTED TO ONE SIDE, CAUSING A PROBLEM TO MAKE INSERTION). THE SURGEON HAS LOTS OF EXPERIENCE WITH MED-EL AND DID NOT USE MUCH FORCE OR PENDING TO ELECTRODE, BUT HAD TO MANIPULATE IT SEVERAL TIMES TO GET IT MORE STRAIGHT. THE USER HAS BEEN EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816469 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER EXPERIENCED FACIAL NERVE PARALYSIS IMMEDIATELY AFTER THE IMPLANTATION SURGERY, REPORTEDLY CAUSED BY THERMAL INJURY. THE CURRENT CONDITION IS GRADE 1 FACIAL PARESIS.

  Patient problems: Facial Paralysis

  MAUDE report 23777460 ↗
• MalfunctionDec 5, 2025Impedance Problem; Impedance Problem

  ON (B)(6) 2025, THE USER FELL OUT OF BED. THE FOLLOWING DAY, THE CHILD REPORTED DISCOMFORT IN THE RIGHT EAR, PREVENTING THE MOTHER FROM PLACING THE AUDIO PROCESSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23725189 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INFECTION IN THE RETRO-AURICULAR AREA WAS OBSERVED. THE ISSUE REPORTEDLY STARTED IN (B)(6) 2025. MEDICAL TREATMENT WAS INITIATED AND THE USER INITIALLY REPORTED IMPROVEMENT. HOWEVER, THE INFECTION RECURRED, LEADING TO THE DECISION TO REMOVE THE DEVICE. THE DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23543875 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER SHOWED SIGNS OF AN ACUTE INFECTION AT THE INCISION SITE, INCLUDING PUS DRAINAGE, REDNESS, AND PAIN. ANTIBIOTICS WERE PRESCRIBED BUT WERE INEFFECTIVE. THE USER WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23511178 ↗
• MalfunctionNov 4, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464007 ↗
• InjuryOct 28, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER REPORTED THAT A WOUND HAS APPEARED OVER THE MAGNET AREA OF THE IMPLANT. THE IMPLANT IS STARTING TO COME OUT.

  Patient problems: Skin Tears

  MAUDE report 23404307 ↗
• MalfunctionOct 16, 2025Impedance Problem; Impedance Problem

  THE USER REPORTS THAT THE SOUND HAS BECOME MUFFLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23310789 ↗
• InjurySep 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER NEEDED AN EMERGENCY EXPLANTATION DUE TO A SEVERE INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 23152110 ↗
• MalfunctionSep 24, 2025Impedance Problem; Impedance Problem

  THE CHILD RESPONDED CORRECTLY TO SPEECH STIMULI DURING LIVE STIMULATION AND WAS ABLE TO REPEAT WORDS IN AN OPEN CONTEXT. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23130517 ↗
• MalfunctionSep 16, 2025Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. RE-POSITIONING SURGERY IS SCHEDULED ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062490 ↗

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-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-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