Distal Jet 3000-0090Recalls & reported problems
Allesee Aoa-Pro · Distal Jet · Class 1
Data updated Oct 16, 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 00889989088014), received between Aug 21, 2024 and Aug 21, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
DOCTOR ALLEGES A BILATERAL DISTAL JET APPLIANCE CAME APART IN THE PATIENT'S MOUTH. DURING REMOVAL OF THE APPLIANCE, THE PATIENT SWALLOWED THE SPRING. THE PATIENT CONFIRMED THE SPRING PASSED NATURALLY WITHOUT INCIDENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20021099 ↗
Other POSITIONER, TOOTH, PREFORMED devices
- Byte Retainer BYTERetainerTrayStraight Smile LLC · Positioner, Tooth, Preformed1,954 reports
- RETAINER KIT 100-0354Access Dental Lab, LLC · Positioner, Tooth, Preformed42 reports
- SureSmile® 1000Orametrix, Inc. · Positioner, Tooth, Preformed39 reports
- SmileSet Retainers 140-0101Ortho Dental Lab LLC · Positioner, Tooth, Preformed17 reports
- ClearCorrect System RetainerClearcorrect Operating, LLC · Positioner, Tooth, Preformed3 reports
- IPS 60-500-01-09KLS-Martin L.P. · POSITIONER, TOOTH, PREFORMED2 reports
- Herbst Bite Jumper 3000-0010Allesee Aoa-Pro · POSITIONER, TOOTH, PREFORMED1 report
- Essix A+ 10045Dentsply Sirona Orthodontics Inc. · POSITIONER, TOOTH, PREFORMED1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page