SONNET 2 CPU Me1510 black 34933Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09008737349332), received between Dec 29, 2022 and Dec 29, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Battery Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE ZINC AIR BATTERIES WERE SWELLING IN THE BATTERY PACK FRAME OF THE EXTERNAL DEVICE SO THAT THE BATTERY PACK COVER WAS DAMAGED. BOTH PARTS WERE REPLACED BY THE CARE CENTER BUT AFTER REPLACING THE BATTERIES THE SAME EVENT HAPPENED AGAIN AND THE BATTERIES WERE SWELLING IN THE BATTERY PACK AGAIN. THERE WAS LEAKING ELECTROLYTE OBSERVED, HOWEVER THE USER DID NOT SUSTAIN ANY INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16068610 ↗

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-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-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