Mi1250 SYNCHRONY 2 MEDIUM S-Vector Magnet 39537Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09008737395377), received between Sep 25, 2023 and May 28, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Electrical Shorting” (1 report).

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.

• MalfunctionMay 28, 2026Impedance Problem

  THE USER REPORTS INSUFFICIENT HEARING PERCEPTION. IMAGING MIGHT BE PERFORMED, NO FURTHER INFORMATION ON FURTHER PROCEEDINGS ARE KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25315016 ↗
• MalfunctionDec 20, 2023Migration; Migration

  THE USER EXPERIENCED MIGRATION OF THE STIMULATOR FROM THE IMPLANT BED TOWARDS THE MASTOID CAVITY, LEADING TO PAIN AND THINNING OF THE SKIN OVER THE IMPLANT. THE MASTOID CAVITY SHOWED SIGNIFICANT FIBROSIS, AND THE ELECTRODE LEAD WAS ALSO FOUND TO BE KINKED. WHILE ATTEMPTING TO REMOVE THE FIBROSIS, THE SURGEON DAMAGED THE ELECTRODE LEAD, SO THE IMPLANT HAD TO BE REPLACED.

  Patient problems: Pain

  MAUDE report 18362500 ↗
• MalfunctionSep 25, 2023Electrical Shorting; Electrical Shorting

  THE USER WAS IMPLANTED ON (B)(6) 2023. HOWEVER, THE ELECTRODE-PLACEMENT WAS NOT OK AND A REVISION-SURGERY OCCURRED ON (B)(6) 2023 WITH RE-INSERTION OF THE ELECTRODE.

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

  MAUDE report 17806007 ↗

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