Mi1250 SYNCHRONY 2 PIN COMPRESSED S-Vector Magnet 39538Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09008737395384), received between Oct 8, 2025 and Nov 18, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Malposition of Device; Impedance Problem; Malposition of Device; Impedance Problem

  AT INTRA-OP MEASUREMENTS AT IMPLANTATION SOME ABNORMAL VALUES WERE DETECTED. A CT-SCAN HAS BEEN ORDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580100 ↗
• InjuryOct 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER THE IMPLANT SURGERY, GRANULATION TISSUE REPEATEDLY APPEARED. THERE WAS AN INFECTION FOLLOWING ACUTE OTITIS MEDIA. DESPITE TAKING ANTIBIOTICS AND OTHER MEDICATIONS, THERE WAS NO IMPROVEMENT. THUS, A REVISION SURGERY WAS SCHEDULED.

  Patient problems: Tissue Breakdown

  MAUDE report 23245868 ↗

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-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. Mi100