Merit Laureate® 00884450033333Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884450033333), received between Nov 11, 2020 and Jan 28, 2026 — classified as 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 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.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Material Separation3
- Material Disintegration1
- Material Fragmentation1
- Material Integrity Problem1
- Particulates1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Foreign Body In Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2026Material Disintegration; Material Separation
THE ACCOUNT ALLEGES DURING A PROCEDURE THE OUTER JACKET OF THE GUIDEWIRE TORE OFF DURING WITHDRAWAL OF THE DEVICE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199366 ↗MalfunctionSep 4, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING A LOWER EXTREMITY ARTERIAL INTERVENTION, THE COATING OF THE WIRE BEGAN TO FLAKE OFF. A TORQUE DEVICE WAS USED DURING THE PROCEDURE TO STEER AND MANIPULATE THE WIRE. A NEW WIRE WAS USED TO FINISH THE PROCEDURE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17680508 ↗MalfunctionAug 18, 2022Particulates; Particulates
THE ACCOUNT ALLEGES THAT DURING AN UP AND OVER PROCEDURE, THE HYDROPHILIC COATING OF THE WIRE SLOUGHED OFF. IN ADDITION, THE PROCEDURE WAS PROLONGED DUE TO DIFFICULTY REMOVING THE WIRE. NO PATIENT INJURY TO REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 15254760 ↗MalfunctionMar 17, 2021Material Fragmentation; Material Fragmentation
A MEDWATCH REPORT (B)(4) ALLEGES THAT DURING A VASCULAR PROCEDURE, THE COATING ON THE HYDROPHILIC GUIDEWIRE SEPARATED OUTSIDE PATIENTS' BODY WHILE BACK LOADING A CATHETER. THE GUIDEWIRE WAS REMOVED AND EXCHANGED FOR A NEW ONE. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11509946 ↗MalfunctionNov 11, 2020Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, THE HYDROPHILIC GUIDEWIRES BLACK JACKET DETACHED WITHIN THE PATIENT. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10824265 ↗InjuryNov 11, 2020Fracture; Material Separation; Fracture; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, THE HYDROPHILIC GUIDEWIRES BLACK JACKET DETACHED WITHIN THE PATIENT. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10824257 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- 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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