Gyrus ACMI 140242-ENTRecalls & reported problems
Gyrus ACMI, LLC · ARMSTRONG BEVELED VENT TUBE GROMMET TYPE 1.14 MM I.D. FLUOROPLASTIC (6/PK) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925035027), received between Apr 14, 2023 and Apr 14, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device Fell” (1 report).
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
Device problems
- Device Fell1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 14, 2023Device Fell; Device Fell
A USER FACILITY REPORTED THAT THE SURGEON DID NOT LIKE THE ARM BEV VENT TB FLPL .045 DEVICE AS THE RIM THAT HELD THE EAR TUBE IN PLACE WAS NOT STURDY ENOUGH. WHEN ASKED FURTHER, IT WAS STATED THAT ON ONE OCCASION IN NOVEMBER OR DECEMBER OF 2022, THE TUBE HAD FALLEN INTO A HOLE IN THE EARDRUM. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16742660 ↗
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- Gyrus ACMI 240044Gyrus ACMI, LLC · TUBE, TYMPANOSTOMY1 recall0 reports
- NeoZoline NZ3321-2Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3306Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3312Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3309Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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