Elation™ 00884450198056Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
- 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 00884450198056), received between Oct 8, 2024 and Oct 8, 2024 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Arrest1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTS THAT WHILE DILATING A STRICTURE LOCATED IN THE PATIENT'S LEFT MAIN BRONCHUS FOR POSSIBLE STENT PLACEMENT IN AN OLDER FEMALE PATIENT, A BLOOD VESSEL WAS PERFORATED AND THE PATIENT STARTED HEMORRHAGING PROFUSELY. A CODE WAS CALLED, AND LIFE-SAVING PROTOCOLS WERE INITIATED WITHOUT SUCCESS. THE PATIENT EXPIRED DUE TO EXTREME BLOOD LOSS/HEMORRHAGING SAME-DAY. THE BALLOON DILATATIONS STARTED AT 15ATMS. THE HIGHEST INFLATION/ATMS REACHED IS CURRENTLY UNKNOWN. THE PHYSICIAN STATED THE PATIENT WAS AT HIGH RISK DUE TO THE STAGE 4 LUNG CANCER DIAGNOSIS.
Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding
MAUDE report 20404249 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.