Merit Laureate® 00884450033289Recalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884450033289), received between Sep 24, 2020 and Feb 21, 2025 — classified as 2 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Material Integrity Problem2
- Material Separation2
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
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 21435246 ↗MalfunctionJul 19, 2023Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) PROCEDURE, THE ACCESS WIRES BLACK JACKET DETACHED WITHIN THE PATIENT WHILE ATTEMPTING ACCESS TO THE PATIENT'S BILIARY SYSTEM. THE PHYSICIAN SUCCESSFULLY EXTERNALIZED THE FOREIGN BODY BY REMOVING THE FOREIGN BODY (JACKET) BY HAND, LIBERATING THE PATIENT FROM THE FOREIGN BODY. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17353670 ↗InjuryMay 30, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING PROCEDURE, THE WIRE TORE OFF IN THE PATIENT. THE DEVICE WAS RETRIEVED. NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17027364 ↗MalfunctionMay 30, 2023Fracture; Material Integrity Problem; Fracture; Material Integrity Problem
THE ACCOUNT ALLEGES THAT DURING A PTBD PROCEDURE THE WIRE BROKE OFF AT THE RADIAL INTRODUCTION. RETRIEVED THE BROKEN PIECES BY HAND. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17027363 ↗InjurySep 24, 2020Material Separation; Material Separation
THE ACCOUNT ALLEGES THAT DURING A PERIPHERAL VASCULAR PROCEDURE, THE HYDROPHILIC GUIDEWIRE TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE FEMORAL ARTERY ACCESS AND HAD NEGOTIATED THE PATIENT'S COMMON ILIAC BIFURCATION. DURING GUIDEWIRE MANIPULATIONS WITHIN THE PATIENT'S CALCIFIED COMMON ILIAC ARTERY THE GUIDEWIRE TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE FOREIGN BODY FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED TO HOME WITH NO ADDITIONAL CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10584502 ↗
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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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