Gyrus ACMI 145224-ENTRecalls & reported problems
Gyrus ACMI, LLC · REUTER-BOBBIN VENT TUBE W/WIRE 1.14 MM ID 1 MM INTERFLANGE FLUOROPLASTIC/STAINLESS (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 00821925038967), received between Nov 17, 2024 and Nov 17, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Expiration Date Error” (1 report).
1 other recall cover devices cleared under the same FDA submission (K820362); 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.
Reports received per month
Most reported problems
Device problems
- Expiration Date Error1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 2024Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT THE TYMPANOSTOMY TUBE WAS IMPLANTED INTO PATIENT THAT WAS EXPIRED WITH THE EXPIRATION DATE OF OCT2022 AFTER IT WAS IMPLANTED INTO THE PATIENT. FOLLOW-UP INDICATED THAT THE PATIENT HAD AN INFECTION. DETAILS OF THE PATIENT'S CURRENT CONDITION, TREATMENT AND PATIENT OUTCOME WERE REQUESTED BUT NOT AVAILABLE AT THE TIME OF THE REPORT.
Patient problems: Unspecified Infection
MAUDE report 20702486 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K820362. One submission often covers many models, so check the product and lot details in each record.
- Z-0797-2010 · Jan 8, 2010 · TerminatedMICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to be implanted for v
Other Tube, Tympanostomy devices
- NeoZoline NZ3312-2Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3321Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- NeoZoline NZ3306-2Adept Medical Limited · Tube, Tympanostomy1 recall0 reports
- 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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