Mi1250 SYNCHRONY 2 PIN FLEX26 S-Vector Magnet 39546Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09008737395469), received between Feb 28, 2022 and Dec 19, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE SKIN OVER THE DEVICE WAS NOT INTACT BEFORE DEVICE REMOVAL SURGERY. REPORTEDLY, THERE WAS A SMALL HOLE IN THE SKIN OVER THE IMPLANT BODY. THE DEVICE WAS EXPLANTED.

  Patient problems: Skin Tears

  MAUDE report 23848092 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER HAD SOME KIND OF HEMATOMA GROWTH AT THE BOTTOM PART OF THE SCAR. THE USER HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23716018 ↗
• InjurySep 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  RETROAURICULAR WOUND HEALING DISORDER WITH INFLAMMATION STARTING IN (B)(6) 2025. IMPLANT IS PARTIALLY EXPOSED. DURING REVISION SURGERY THE IMPLANT WAS MOVED BACK INTO THE IMPLANT BED, HOWEVER, THE ELECTRODE ARRAY WAS INADVERTENTLY PULLED OUT OF THE COCHLEA, THUS ANOTHER REVISION SURGERY WAS SCHEDULED. DURING THE SECOND REVISION SURGERY THE ELECTRODE WAS MISPLACED IN THE SEMICIRCULAR CANAL. EVENTUALLY THE USER HAS BEEN REIMPLANTED.

  Patient problems: Skin Tears

  MAUDE report 23176937 ↗
• InjuryFeb 28, 2022Device Appears to Trigger Rejection; Migration; Device Appears to Trigger Rejection; Migration

  THE DEVICE WAS EXPLANTED AS IT MIGRATED AND BROKE THROUGH THE SKIN. THE ELECTRODE WAS CUT OFF AND LEFT IN THE COCHLEA FOR LATER REIMPLANTATION.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 13617436 ↗

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