Merit Laureate® 00884450033296Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450033296), received between Dec 15, 2022 and May 6, 2025 — classified as 1 injury, 2 malfunctions.
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. 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
- Material Fragmentation1
- Material Separation1
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 6, 2025Unraveled Material; Unraveled Material
THE ACCOUNT ALLEGES DURING THE PROCEDURE THE COATING WAS COMING OFF THE LAUREATE WIRE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21973368 ↗MalfunctionFeb 21, 2025Material Fragmentation; Material Fragmentation
THE ACCOUNT ALLEGES THAT DURING THE PROCEDURE, WHILE ATTEMPTING TO INTRODUCE AN INTERVENTIONAL DEVICE OVER THE GUIDEWIRE, THE COATING OF THE GUIDEWIRE STARTED COMING OFF ONTO THE OPERATOR'S GLOVES. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21435229 ↗InjuryDec 15, 2022Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT DURING AN INTERVENTIONAL PERIPHERAL VASCULAR PROCEDURE WHEN ATTEMPTING TO RE-CANNULATE THE OSTIUM OF THE TARGETED VESSEL, THE GUIDEWIRE'S BLACK OUTER JACKET DETACHED WITHIN THE PATIENT. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY VIA MEDICAL INTERVENTION. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15988153 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 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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