Mi1250 SYNCHRONY 2 PIN STANDARD 36671Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09008737366711), received between Dec 21, 2020 and Jan 18, 2022 — 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.

• MalfunctionJan 18, 2022Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  THE USER WAS IMPLANTED ON (B)(6) 2021. AFTER THE FIRST FITTING THE AUDIOLOGIST FELT THE USER'S HEARING SHOULD BE BETTER AND THEY INFORMED THE CLINICAL ENGINEER. ON (B)(6) 2022 THE USER REPORTED THAT HE IS ABLE TO HEAR WELL WHEN HE IS HOLDING THE AUDIO PROCESSOR (AP) AT A SPECIFIC ANGLE. ADDITIONAL TESTING WILL BE CONDUCTED.

  Patient problems: Failure of Implant; Unspecified Nervous System Problem

  MAUDE report 13281079 ↗
• InjuryDec 21, 2020Device Appears to Trigger Rejection; Insufficient Device Problem Information; Device Appears to Trigger Rejection; Insufficient Device Problem Information

  IN LATE NOVEMBER/BEGINNING OF (B)(6) 2020, THE USER DEVELOPED AN INFECTION AND THEN A BREAKDOWN OF SKIN AROUND THE IMPLANT SITE. PARTS OF THE STIMULATOR COIL WERE VISIBLE WHEN THE RECIPIENT WENT TO THE CLINIC ON (B)(6) 2020. THE DEVICE WAS EXPLANTED ON THE (B)(6) 2020 AND THE WOUND WAS COVERED.

  Patient problems: Unspecified Infection

  MAUDE report 11045662 ↗

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-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-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