Merit Laureate® 00884450033302Recalls & 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450033302), received between Dec 27, 2018 and Jun 3, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation3
- Fracture2
Patient problems
- Foreign Body In Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗InjuryDec 27, 2018Material Separation
APPROX 10 CM SECTION OF GLIDEWIRE PROXIMAL TO TIP SEPARATED FROM CORE AND REMAINED IN LEFT ANTERIOR TIBIAL ARTERY WHEN WIRE WAS REMOVED. REQUIRED ANGIOPLASTY AND SNARE DEVICE FOR REMOVAL OF REMAINING WIRE FRAGMENT, REQUIRING ADD'L IMAGING WITH IODINATED CONTRAST MEDIA. DIAGNOSIS OR REASON FOR USE: ANGIOGRAPHY AND PERIPHERAL INTERVENTION. IS THE PRODUCT COMPOUNDED? NO; IS THE PRODUCT OVER-THE-COUNTER? NO.
Patient problems: Foreign Body In Patient
MAUDE report 8203194 ↗
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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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