Elation™ 00884450399019Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00884450399019), received between Aug 27, 2025 and Aug 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inflation Problem” (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
- Inflation Problem1
- Infusion or Flow Problem1
- Mechanical Problem1
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.
MalfunctionAug 27, 2025Inflation Problem; Mechanical Problem; Infusion or Flow Problem; Inflation Problem; Mechanical Problem; Infusion or Flow Problem
THE ACCOUNT ALLEGES THAT WHILE USING THE PULMONARY BALLOON TO DILATE THE RIGHT MAIN BRONCHUS, THE BALLOON FAILED TO INFLATE AND FLUID WAS SPITTING OUT WHEN TRYING TO INFLATE. IN LOOKING AT THE DEVICES BEING USED, BOTH WERE INCORRECTLY LABELED AS BALLOON. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22909985 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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