Insertion Probe 33563Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09008737335632), received between Apr 2, 2025 and Apr 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “No Device Output” (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.

• MalfunctionApr 2, 2025No Device Output; No Device Output

  ACCORDING TO THE USER'S MOTHER THE USER WAS STANDING IN THE KITCHEN WHEN SHE PASSED OUT. AS SHE FELL, SHE HIT HER RIGHT SIDE. THE MOTHER THINKS SHE MOSTLY HIT HER RIGHT SHOULDER, ALTHOUGH HER PROCESSOR COIL FLEW OFF AND THE AUDIOSTREAM COVER BROKE. WHEN REASSEMBLING THE EXTERNAL DEVICES, THE USER COULD NO LONGER HEAR. THE USER'S MOTHER HAD TRIED A BACK UP PROCESSOR AND THE RECIPIENT COULD STILL NOT HEAR. AFTER REPLACING PARTS ON THE SONNET PROCESSOR, THE USER COULD NO LONGER HEAR WITH THE ORIGINAL PROCESSOR EITHER. PROCESSOR AND DL COIL LIGHTS WERE FUNCTIONING NORMALLY ON THE SONNET. MOM HAD A SPEECH PROCESSOR TEST DEVICE (SPTD) AND THE SPTD INDICATED THAT BOTH PROCESSORS WERE FUNCTIONING NORMALLY.

  Patient problems: Head Injury

  MAUDE report 21749784 ↗

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-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
• 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