Merit Laureate® 00884450033340Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450033340), received between Nov 25, 2019 and Jan 26, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryJan 26, 2021Material Separation; Material Separation

  DURING A PERIPHERAL ANGIOGRAM, THE GUIDEWIRES HYDROPHILIC COATING DETACHED WITHIN THE PATIENT'S RIGHT LEG. THE PHYSICIAN WAS NOT ABLE TO RETRIEVE THE FOREIGN BODY FROM THE PATIENT. THE PROCEDURE WAS CANCELLED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11233316 ↗
• InjuryNov 27, 2019Break; Fracture; Break; Fracture

  THE ACCOUNT ALLEGES THAT DURING BILATERAL RECANALIZATION OF AN ILIAC ARTERY, 5CM OF THE HYDROPHILIC GUIDEWIRE TIP DETACHED WITHIN THE PATIENT'S VASCULATURE. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL VASCULAR ACCESS AND DURING GUIDEWIRE AND CATHETER MANIPULATIONS WITHIN THE COMMON ILIAC ARTERY, THE TIP DETACHED WITH THE PATIENT. THE PHYSICIAN NOTED THAT DURING GUIDEWIRE MANIPULATIONS, RESISTANCE AND TORTUOSITY WAS NOT EXPERIENCED DURING WIRE MANIPULATIONS. THE PHYSICIAN DEPLOYED A COVERED PERIPHERAL VASCULAR STENT-GRAFT TO BOTH TREAT THE PATIENT'S VASCULATURE DISEASE AND ENTRAP THE DETACHED WIRE TIP BETWEEN THE ARTERIAL LUMEN AND STENT-GRAFT, PREVENTING WIRE TIP MIGRATION. THE PATIENT TOLERATED THE PROCEDURE WELL. NO ADDITIONAL CONSEQUENCES TO REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9385096 ↗
• InjuryNov 25, 2019Break; Fracture; Break; Fracture

  THE ACCOUNT ALLEGES THAT DURING A PERCUTANEOUS TRANSLUMINAL PERIPHERAL VASCULAR PROCEDURE, THE HYDROPHILIC GUIDE WIRE TIP DETACHED WITHIN THE PATIENT. THE PHYSICIAN HAD ACQUIRED RETROGRADE ARTERIAL VASCULAR ACCESS IN AN ATTEMPT TO RE-CANNULATE THE PATIENT'S LEFT COMMON ILIAC ARTERY. DURING GUIDE WIRE MANIPULATION'S THE TIP DETACHED. THE PHYSICIAN USED A VASCULAR SNARE DEVICE TO SUCCESSFULLY RETRIEVE THE GUIDE WIRE TIP FROM THE PATIENT WITH NO ADDITIONAL CONSEQUENCES TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9371070 ↗