Avoset Back check valve set 12222-000-0001Recalls & reported problems
Eitan Medical Ltd · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 17290109152223), received between Aug 20, 2024 and May 6, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (6 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/Splash6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2026Leak/Splash
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM THE USA. A LEAKAGE ISSUE WAS REPORTED. NO HUMAN HARM OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25091269 ↗MalfunctionJul 24, 2025Leak/Splash; Leak/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 AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22584931 ↗MalfunctionJun 30, 2025Leak/Splash; Leak/Splash
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM THE US. A LEAKAGE ISSUE WAS REPORTED. IT WAS REPORTED THAT NO HUMAN HARM OCCURRED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22357940 ↗MalfunctionSep 5, 2024Leak/Splash; Leak/Splash
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM THE USA. LEAKAGE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20145640 ↗MalfunctionAug 20, 2024Leak/Splash; Leak/Splash
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM USA.LEAKAGE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20006032 ↗MalfunctionAug 20, 2024Leak/Splash; Leak/Splash
THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM (B)(6). LEAKAGE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20001768 ↗
Other Set, Administration, Intravascular devices
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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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