Avoset Cartridge Set 12222-000-0002Recalls & reported problems
Eitan Medical Ltd · 100 ML MEDICATION RESERVOIR WITH FREE-FLOW PROTECTION, SLIDE CLAMP AND FEMALE LUER LOCK. NONVENTED STOPPER INCLUDED. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 17290109152568), received between Feb 11, 2026 and Jun 11, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 reports).
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
- Leak/Splash4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Leak/Splash
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA. A LEAKAGE ISSUE WAS REPORTED. IT WAS REPORTED THAT NO HUMAN HARM OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25469389 ↗MalfunctionApr 14, 2026Leak/Splash
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA. A LEAKAGE ISSUE WAS REPORTED. IT WAS REPORTED NO HUMAN HARM OCCURRED, AND NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24873831 ↗MalfunctionMar 30, 2026Leak/Splash
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA. A LEAKAGE ISSUE WAS REPORTED. IT WAS REPORTED NO HUMAN HARM OCCURED, AND NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24723940 ↗MalfunctionFeb 11, 2026Leak/Splash
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA. A LEAKAGE ISSUE WAS REPORTED. NO HUMAN HARM OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24312977 ↗
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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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