Mi1260 SONATA 2 FLEX26 38544Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 09008737385446), received between May 22, 2024 and Sep 8, 2026 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026No Device Output

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670065 ↗
• MalfunctionApr 15, 2026Device Dislodged or Dislocated

  The user, who is bilaterally implanted, presented two months ago with a spontaneous hematoma, without trauma, in the right temporal region over the magnet of the right cochlear implant. A revision surgery was performed to clean and drain the hematoma in (b)(6) 2026. During the procedure, it was observed that the magnet was outside the pocket.

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 24882533 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  THE LEFT IMPLANT WAS EXPLANTED DUE TO AN INFECTION THAT COULD NOT BE CONTROLLED. ACCORDING TO THE EXPLANTATION REPORT, THE USER ALSO HAD PAIN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24577708 ↗
• MalfunctionJan 14, 2026Impedance Problem

  THE USER SUFFERED FROM A TRAUMA.

  Patient problems: Head Injury

  MAUDE report 24065671 ↗
• MalfunctionSep 11, 2025Impedance Problem; Impedance Problem

  THE USER REPORTS A DECREASE IN SOUND PERCEPTION. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Fibrosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023971 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A RECENT FITTING SESSION, THE AUDIOLOGIST ADJUSTED THE STIMULATION PARAMETERS BY MODIFYING THE MINIMUM PULSE DURATION AND SWITCHING FROM BIPHASIC TO TRIPHASIC PULSES. DESPITE THESE ADJUSTMENTS, THE USER CONTINUED TO EXPERIENCE FACIAL NERVE STIMULATION, BOTH WITH AND WITHOUT THE AUDIO PROCESSOR (AP) IN PLACE. FOLLOWING A CALIBRATION SESSION, THE USER INITIALLY REPORTED AN IMPROVEMENT. HOWEVER, THE FACIAL STIMULATION SYMPTOMS REAPPEARED A FEW DAYS LATER AND THE USER IS STILL SUFFERING BY FNS AT THE MOMENT. FURTHER PROCEEDINGS ARE CURRENTLY UNKNOWN.

  Patient problems: Facial Paralysis

  MAUDE report 22892979 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT DEVELOPED A SKIN INFECTION AROUND THE AUDIO PROCESSOR. REPORTEDLY, THERE WAS A SUBCUTANEOUS INFLAMMATION. THE SKIN INFECTION STARTED IN (B)(6) 2025. ANTIBIOTIC TREATMENT WAS GIVEN, BUT DID NOT RESOLVE THE ISSUE, AND THEREFORE THE DEVICE WAS EXPLANTED. RE-IMPLANTATION IS PLANNED AT A LATER POINT IN TIME.

  Patient problems: Skin Infection

  MAUDE report 22183323 ↗
• MalfunctionMay 9, 2025Migration; Migration

  DURING THE LAST FITTING APPOINTMENT HIGH IMPEDANCES IN THE BASAL CHANNELS WERE OBSERVED AND THE RECIPIENT HAD NOT HEARING SENSATION WITH THE DEVICE. A REVISION SURGERY WAS PERFORMED TO REINSERT THE ELECTRODE AND USED A FIXATION CLIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992586 ↗
• InjuryApr 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT HAD A SKIN INFECTION AT THE IMPLANT SITE FOR THE SECOND TIME. THERE WAS A SKIN NECROSIS WITH OPENING OF THE SKIN. ANTIBIOTIC TREATMENT WAS PROVIDED, HOWEVER DID NOT RESOLVE THE ISSUE. CULTURES WERE PERFORMED AND SHOWED PSEUDOMONAS AERUGINOSA. THE RECIPIENT HAS BEEN EXPLANTED.

  Patient problems: Skin Infection

  MAUDE report 21785009 ↗
• MalfunctionFeb 14, 2025Impedance Problem; Impedance Problem

  DURING A FOLLOW-UP APPOINTMENT, IN SITU TESTING WAS PERFORMED WHERE AFFECTED CHANNELS WERE OBSERVED. THE RECIPIENT WILL BE MONITORED, RE-IMPLANTATION MIGHT BE CONSIDERED.

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

  MAUDE report 21382732 ↗
• InjuryDec 9, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE USER VISITED THE CLINIC WITH EAR SUPPURATION AND AN EXTRUDED ELECTRODE LEAD IN THE EXTERNAL AUDITORY CANAL (EAC). THE USER HAS BEEN EXPLANTED. ACCORDING TO THE EXPLANT REPORT FORM, THE ELECTRODE ARRAY WAS FOUND OUTSIDE THE COCHLEA PRIOR TO REMOVAL.

  Patient problems: Skin Tears

  MAUDE report 20875822 ↗
• MalfunctionAug 30, 2024Migration; Migration

  THE RECIPIENT'S SPEECH UNDERSTANDING AND PERFORMANCE WITH THE DEVICE HAS GONE POORER ALL THE TIME AND SOUND WAS NOT GOOD AT ALL. RE-INSERTION SCHEDULED FOR (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 20104956 ↗
• MalfunctionAug 9, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE RECIPIENT REPORTED THAT HE DOES NOT HEAR ANYTHING AND HAS NO BENEFIT FROM THE DEVICE. CURRENTLY, THE RECIPIENT DOES NOT RESPOND TO ANY CHARGE INCREASE AND REPORTED DISCOMFORT UNDER CHARGE INCREASE. EABR TESTING IS CONSIDERED. THE SURGEON HAS SCHEDULED AN APPOINTMENT FOR (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 19947354 ↗
• InjuryMay 22, 2024Microbial Contamination of Device; Microbial Contamination of Device

  THE RECIPIENT HAD A SKIN INFECTION WITH NECROSIS AT THE IMPLANT SITE AND WAS TREATED WITH ANTIBIOTICS FOR 1 MONTH. THE DEVICE WAS VISIBLE THROUGH THE WOUND. REPORTEDLY, THE SURGICAL WOUND COMPLETELY HEALED AFTER INITIAL IMPLANTATION. THE RECIPIENT HAS BEEN EXPLANTED. THE RECIPIENT HAS BEEN IMPLANTED ON THE CONTRA-LATERAL SIDE.

  Patient problems: Bacterial Infection

  MAUDE report 19369443 ↗

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. Mi1000 CONCE
• 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 Product