Merit Laureate® 00884450033319Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
All models of Merit Laureate (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450033319), received between Dec 10, 2020 and Mar 18, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Separation” (2 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.
Most reported problems
Device problems
- Material Separation2
Patient problems
- Foreign Body In Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 18, 2021Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT DURING A URETEROSCOPY PROCEDURE, 10CM OF THE HYDROPHILIC GUIDE WIRE'S COATING DETACHED WITHIN THE PATIENT'S URETER. A NEW GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 11517533 ↗InjuryDec 10, 2020Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT DURING A URETEROSCOPY PROCEDURE, 10CM OF THE HYDROPHILIC GUIDE WIRE'S COATING DETACHED WITHIN THE PATIENT'S URETER. A NEW GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 10985345 ↗
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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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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