Hummingbird Tympanostomy Tube System 05-1001-653Recalls & reported problems
Preceptis Medical, Inc · 05-1001-653, +90 Inserter With Pre-loaded Vent Tube · 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 00853386007077), received between Jun 3, 2024 and Jun 3, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Malposition of Device” (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.
Reports received per month
Most reported problems
Device problems
- Malposition of Device1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 3, 2024Malposition of Device; Malposition of Device
CLINICIAN REPORTED PLACING EAR TUBES IN HER CLINIC IN A 4-YEAR OLD FEMALE PATIENT USING THE HUMMINGBIRD TYMPANOSTOMY TUBE SYSTEM. THE SYSTEM WAS USED TO SUCCESSFULLY PLACE A TYMPANOSTOMY TUBE (TT) IN THE FIRST EAR. IN THE SECOND EAR, THE CHILD'S HEAD MOVED SLIGHTLY DURING THE PROCEDURE, CAUSING THE TUBE TO BE DELIVERED MEDIALLY INTO THE MIDDLE EAR SPACE. THE CLINICIAN ATTEMPTED TO RETRIEVE THE TT, BUT WAS NOT ABLE TO EXTRACT IT DURING THE PROCEDURE IN THE OFFICE. AN OPERATING ROOM FOLLOW-UP TO LOCATE AND EXTRACT THE TUBE UNDER GENERAL ANESTHESIA WAS SCHEDULED. THE FOLLOW-UP PROCEDURE WAS NOT ABLE TO LOCATE THE TT IN THE MIDDLE EAR SPACE. THE DOCTOR REPORTS THAT PATIENT HAS NO SYMPTOMS RELATED TO THE MEDIALIZED TUBE AND THERE IS NO ADVERSE IMPACT ON PATIENT HEARING. PATIENT WILL BE MONITORED FOR SYMPTOMS AND APPROPRIATE ACTION TAKEN IF ANY OCCUR.
Patient problems: Foreign Body In Patient
MAUDE report 19455287 ↗
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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