Mi1250 SYNCHRONY 2 PIN STANDARD S-Vector Magnet 39534Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09008737395346), received between Jul 18, 2024 and Aug 31, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Device Appears to Trigger Rejection

  Symptoms leading to explantation were wound infection and implant extrusion. Reportedly, the user will decide in the future if he wants an implant. The electrode array was left in the cochlea.

  Patient problems: Wound Infection

  MAUDE report 50517771 ↗
• InjuryDec 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE WAS EXPLANTED AS THE PATIENT SUFFERED FROM WOUND DEHISCENCE. THE IMPLANT EXTRUDED THROUGH THE OLD INCISION.

  Patient problems: Skin Tears

  MAUDE report 23725751 ↗
• InjuryOct 6, 2025Device Appears to Trigger Rejection; Microbial Contamination of Device; Device Appears to Trigger Rejection; Microbial Contamination of Device

  THE RECIPIENT DEVELOPED AN INFECTION THAT COULD NOT BE RESOLVED THROUGH TREATMENT. AS A RESULT, THE DEVICE WAS EXPLANTED.

  Patient problems: Bacterial Infection; Tissue Breakdown

  MAUDE report 23220602 ↗
• InjuryJul 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER'S RIGHT-SIDED IMPLANT WAS EXPLANTED. REPORTS INDICATED THAT THE IMPLANT EXTRUDED AND THERE WAS INFECTION AND NECROSIS IN THE SURROUNDING IMPLANT AREA. THE USER HAS BEEN RE-IMPLANTED WITH A NEW DEVICE ON (B)(6) 2024.

  Patient problems: Skin Tears

  MAUDE report 19769356 ↗
• InjuryJul 18, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER'S LEFT-SIDED IMPLANT WAS EXPLANTED. REPORTS INDICATED THAT THE IMPLANT EXTRUDED AND THERE WAS INFECTION AND NECROSIS IN THE SURROUNDING IMPLANT AREA.

  Patient problems: Skin Tears

  MAUDE report 19769239 ↗

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