Mi1250 SYNCHRONY 2 PIN MEDIUM S-Vector Magnet 39536Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09008737395360), received between Jun 21, 2022 and Mar 7, 2024 — classified as 2 injuries, 1 malfunction.

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.

• InjuryMar 7, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SIMILAR TO THE CONTRALATERAL SIDE THE IMPLANT EXTRUDED THROUGH THE SKIN. ON THIS SIDE THE UPPER EDGE OF THE COIL SECTION WAS AFFECTED. INITIALLY, THE WOUND HEALED COMPLETELY AND APPEARED TO BE UNREMARKABLE. SINCE THE MIDDLE OF LAST YEAR (JULY 2023) PROBLEMS WITH THE SKIN OVER BOTH IMPLANTS HAVE BEEN REPORTED. WHEN THE CONTRALATERAL SIDE WAS EXPLANTED SAMPLES FROM THE IMPLANT AREA WERE TAKEN AND ANALYZED BUT DID NOT REVEAL ANY BACTERIAL INFECTION. THE HOSPITAL TRIED TO TREAT THE AFFECTED SKIN AREA CONSERVATIVELY WITH ANTI-INFLAMMATORY CREAM. THE DEVICE WAS EXPLANTED.

  Patient problems: Skin Tears

  MAUDE report 18854842 ↗
• InjuryOct 19, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE IMPLANT HOUSING EXTRUDED. TO MANAGE THE RESULTING INFECTION, ANTIBIOTICS WERE PRESCRIBED AND THE IMPLANT WAS REMOVED. THE ISSUE STARTED ABOUT 3 MONTH AFTER THE IMPLANTATION. RE-IMPLANTATION IS PLANNED IN ABOUT 6 MONTHS.

  Patient problems: Skin Tears

  MAUDE report 17963891 ↗
• MalfunctionJun 21, 2022Output Problem; Output Problem

  THE CLINIC REPORTEDLY HAD DIFFICULTIES WITH THE INTRAOPERATIVE MEASUREMENTS. AFTER TROUBLESHOOTING, THE USER WAS RE-IMPLANTED WITH A BACKUP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14751917 ↗

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-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
• 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