Gyrus ACMI 245775Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00821925032439), received between May 21, 2021 and Apr 21, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (K932166); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THIS TYMPANOSTOMY TUBE HAD MIGRATED TO MIDDLE EAR AND SKIN HEALED OVER IT. A SURGICAL INTERVENTION WAS PERFORMED TO REMOVE A FOREIGN BODY IN LEFT MIDDLE EAR AND AN EAR PATCH WAS APPLIED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16791880 ↗
• InjuryApr 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THIS TYMPANOSTOMY TUBE HAD MIGRATED TO MIDDLE EAR AND SKIN HEALED OVER IT. A SURGICAL INTERVENTION WAS PERFORMED TO REMOVE A FOREIGN BODY IN RIGHT MIDDLE EAR AND AN EAR PATCH WAS APPLIED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16791728 ↗
• InjuryJan 5, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  THE CUSTOMER REPORTS A PATIENT HAD AN ADENOIDECTOMY AND RIGHT EAR DURAVENT TUBE PLACEMENT , NO ISSUES REPORTED. ONE YEAR, AND 17 DAYS LATER, THE PATIENT REQUIRED A MYRINGOTOMY AND TYMPANOSTOMY (M+T) PROCEDURE AND FOREIGN BODY RETRIEVAL (OF THE DURAVENT EAR TUBE) DUE TO MIGRATION OF THE DURAVENT INTO THE MIDDLE EAR. THERE WERE NO ADDITIONAL CONSEQUENCES TO THE PATIENT REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13172828 ↗
• InjuryDec 14, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PHYSICIAN REPORTS TWO CASES OF DURAVENT TUBE MIGRATION TO THE MIDDLE EAR. FOR THIS CASE, THE PATIENT UNDERWENT A BILATERAL MYRINGOTOMY AND TYMPANOSTOMY (M+T). THREE YEARS, FOUR MONTHS LATER, THE PATIENT REQUIRED A SURGICAL PROCEDURE TO REMOVE RIGHT MIDDLE EAR FOREIGN BODY USING AN OPERATING MICROSCOPE. NO FURTHER CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1/2. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2/2.

  Patient problems: Foreign Body In Patient

  MAUDE report 13001503 ↗
• InjuryDec 14, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PHYSICIAN REPORTS TWO CASES OF DURAVENT TUBE MIGRATION TO THE MIDDLE EAR. FOR THIS CASE, THE PATIENT UNDERWENT A BILATERAL MYRINGOTOMY AND TYMPANOSTOMY (M+T). FOUR YEARS, SEVEN MONTHS AND 14 DAYS LATER, THE PATIENT REQUIRED A SURGICAL PROCEDURE TO REMOVE RIGHT MIDDLE EAR FOREIGN BODY USING AN OPERATING MICROSCOPE AND EPIDISC. NO FURTHER CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 1/2. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PATIENT 2/2.

  Patient problems: Foreign Body In Patient

  MAUDE report 13001463 ↗
• InjuryJun 8, 2021Difficult to Remove; Difficult to Remove

  IT IS REPORTED ONE YEAR, EIGHT MONTHS AND 22 DAYS AFTER A DURAVENT TUBE WAS PLACED DURING A BILATERAL MYRINGOTOMY AND TUBES (BM-T) PROCEDURE, SKIN HEALED OVER THE DURAVENT TUBE REQUIRING A SURGICAL INCISION TO BE MADE TO REMOVE THE DEVICE. SEQUENCE OF EVENTS AS FOLLOWS: (B)(6) 2018: TUBE BM-T. A DURAVENT TUBE WAS PLACED. (B)(6) 2020: RIGHT INNER EAR FOREIGN BODY REMOVAL. DURAVENT TUBE WAS SURGICALLY REMOVED FROM INNER EAR. PROCEDURE COMPLETED UNDER ANESTHESIA WITH MICROSCOPE. INCISION WAS REQUIRED AS SKIN HEALED OVER THE DURAVENT TUBE. THERE WERE NO ADDITIONAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11956740 ↗
• InjuryJun 7, 2021Difficult to Remove; Difficult to Remove

  IT IS REPORTED TWO YEARS, THREE MONTHS AND 26 DAYS AFTER A DURAVENT TUBE WAS PLACED DURING A LEFT MYRINGOTOMY AND BILATERAL MYRINGOTOMY AND TUBES (BM-T) PROCEDURE, SKIN HEALED OVER THE DURAVENT TUBE REQUIRING A SURGICAL INCISION TO BE MADE TO REMOVE THE DEVICE. SEQUENCE OF EVENTS AS FOLLOWS: (B)(6) 2019: LEFT MYRINGOTOMY AND TUBE BM-T. A DURAVENT TUBE WAS PLACED. (B)(6) 2021: LEFT INNER EAR FOREIGN BODY REMOVAL. DURAVENT TUBE WAS SURGICALLY REMOVED FROM INNER EAR. PROCEDURE COMPLETED UNDER ANESTHESIA WITH MICROSCOPE. INCISION WAS REQUIRED AS SKIN HEALED OVER THE DURAVENT TUBE. THERE WERE NO ADDITIONAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11952061 ↗
• InjuryJun 7, 2021Difficult to Remove; Difficult to Remove

  IT IS REPORTED ONE YEAR, SIX MONTHS AND 19 DAYS AFTER A DURAVENT TUBE WAS PLACED DURING A BILATERAL MYRINGOTOMY AND TUBES (BM-T) PROCEDURE, SKIN HEALED OVER THE DURAVENT TUBE REQUIRING A SURGICAL INCISION TO BE MADE TO REMOVE THE DEVICE. SEQUENCE OF EVENTS AS FOLLOWS: (B)(6) 2019: TUBE BM-T. A DURAVENT TUBE WAS PLACED. (B)(6) 2021: RIGHT INNER EAR FOREIGN BODY REMOVAL. DURAVENT TUBE WAS SURGICALLY REMOVED FROM INNER EAR. PROCEDURE COMPLETED UNDER ANESTHESIA WITH MICROSCOPE. INCISION WAS REQUIRED AS SKIN HEALED OVER THE DURAVENT TUBE. THERE WERE NO ADDITIONAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11952047 ↗
• InjuryMay 21, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  IT IS REPORTED AN UNSPECIFIED TIME FRAME AFTER A PROCEDURE TO IMPLANT A DURAVENT TYMPANOSTOMY TUBE, THE TUBE MIGRATED TO THE INNER EAR AND REQUIRED SURGICAL INTERVENTION TO REMOVE IT. NO ADDITIONAL CONSEQUENCES TO THE PATIENT HAVE BEEN REPORTED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11862125 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K932166. One submission often covers many models, so check the product and lot details in each record.

• Z-0707-2025 · Nov 19, 2024 · Open, Classified
  Duravent Silicone Ventilation Tube. Model Number: 240075.
• Z-1004-2024 · Dec 11, 2023 · Open, Classified
  Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044