Ethox 950089904Recalls & reported problems
Ethox Medical, LLC · ETHOX 4030 INFU-SU 3000ML PRESSURE IN · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20889483149826), received between Oct 25, 2023 and Oct 25, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 25, 2023Material Fragmentation; Material Fragmentation
BAG EXPLODED WHILE IT WAS BEING PUMPED UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18008509 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.