DL-Coil Base, Black 31304Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09008737313043), received between Oct 2, 2018 and May 10, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Output Problem” (2 reports).

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 10, 2019Output Problem; Output Problem

  IT WAS OBSERVED THAT THE BOTTOM OF THE DL-COIL BASE PART BROKE DOWN AFTER 3-6 MONTHS OF USE. THE DL-COIL HAD A #2 STRENGTH MAGNET. THE DL-COIL WAS REPLACED. NO INJURY (I.E. SKIN LACERATION) OR SKIN IRRITATION OVER THE IMPLANT AREA HAS BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8599144 ↗
• MalfunctionMay 10, 2019Output Problem; Output Problem

  IT WAS OBSERVED THAT THE BOTTOM OF THE DL-COIL BASE PART BROKE DOWN AFTER 3-6 MONTHS OF USE. THE DL-COIL HAD A #2 STRENGTH MAGNET. THE DL-COIL WAS REPLACED. NO INJURY (I.E. SKIN LACERATION) OR SKIN IRRITATION OVER THE IMPLANT AREA HAS BEEN REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8599033 ↗
• MalfunctionOct 2, 2018Insufficient Device Problem Information; Device Handling Problem; Insufficient Device Problem Information; Device Handling Problem

  IT WAS REPORTED THAT SIGNS OF PRESSURE COULD BE SEEN ON THE BOTTOM OF THE DL-COIL AND D COIL BASE PARTS FROM WHERE THE MAGNET IS PRESSING AGAINST IT. THERE HAS BEEN NO INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7925080 ↗

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