Merit LaureateRecalls & reported problems across all models

We found 6 models of Merit Laureate by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Dec 27, 2018 and Jan 28, 2026 — classified as 12 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Material Separation” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Merit Laureate problems

Merit Laureate models

6 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Merit Laureate® 00884450033333

  WIRE, GUIDE, CATHETER
  6 reports
• Merit Laureate® 00884450033289

  WIRE, GUIDE, CATHETER
  5 reports
• Merit Laureate® 00884450033340

  WIRE, GUIDE, CATHETER
  4 reports
• Merit Laureate® 00884450033296

  WIRE, GUIDE, CATHETER
  3 reports
• Merit Laureate® 00884450033302

  WIRE, GUIDE, CATHETER
  3 reports
• Merit Laureate® 00884450033319

  WIRE, GUIDE, CATHETER
  2 reports

Recent Merit Laureate adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryJun 3, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES WHILE PERFORMING A LOWER CAVITY FILTER REMOVAL SURGERY, THE GUIDE WIRE LOOP FORMATION TECHNIQUE WAS USED. WHEN PULLING THE FILTER WITH THE DEVICE, THE END OF THE GUIDE WIRE FELL OFF WITHIN THE PATIENT. THE FOREIGN BODY WAS SUCCESSFULLY RETRIEVED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137599 ↗
• 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 21435246 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryDec 6, 2022Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT THE PATIENT PRESENTED FOR IVC (INFERIOR VENA CAVA) FILTER REMOVAL. A J-WIRE INSERTED DOWN THE SVC(SUPERIOR VENA CAVA) TO THE IVC UNDER FLUOROSCOPIC GUIDANCE. MULTIPLE ATTEMPTS MADE TO SNARE THE HOOK OF THE FILTER. UNABLE TO SNARE THE FILTER. UPON TRYING TO RETRIEVE THE FILTER WITH THE SNARE, THE TIP OF THE WIRE BROKE OFF AND WENT UPSTREAM. CARDIOTHORACIC SURGERY CONSULTED. RECOMMENDED ANTICOAGULATION. PATIENT WAS ULTIMATELY TRANSFERRED TO UNIVERSITY FOR INTERVENTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 15928416 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJan 26, 2021Material Separation; Material Separation

  THE ACCOUNT ALLEGES THAT DURING A PROCEDURE WHEN INTRODUCING THE HYDROPHILIC GUIDEWIRE INTO A 6F SHEATH, THE BLACK JACKET DETACHED FROM THE HYDROPHILIC GUIDWIRE. NO FOREIGN BODY INTRODUCTION. NO PATIENT INJURY TO REPORT. A NEW GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11233421 ↗

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