ASAHI Gladius Mongo14 AP14R323SRecalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
All models of ASAHI Gladius Mongo14 (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04547327123709), received between Feb 25, 2025 and Feb 25, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (1 report).
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 Separation1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 25, 2025Material Separation; Material Separation
IT WAS REPORTED THAT AN ASAHI GLADIUS MONGO14 GUIDE WIRE WAS USED WITH AN ASAHI CORSAIR PRO XS MICROCATHETER TO APPROACH A MODERATELY CALCIFIED AND MODERATELY TORTUOUS CHRONIC TOTAL OCCLUSION (CTO) CAUSED BY IN-STENT RESTENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA) DURING PERCUTANEOUS CORONARY INTERVENTION (PCI). THE GLADIUS MONGO14 GUIDE WIRE MET RESISTANCE AT THE PROXIMAL CAP OF THE CTO, BUT WAS ADVANCED IN AN ATTEMPT TO CROSS THE LESION. WHEN WITHDRAWAL FROM THE CORSAIR PRO XS MICROCATHETER WAS ATTEMPTED, THE DISTAL SEGMENT OF THE GLADIUS MONGO14 GUIDE WIRE WAS FRACTURED. IT WAS INFORMED THAT THE DETACHED FRAGMENT WAS STENTED TO THE VESSEL WALL, AND THE PATIENT WAS DISCHARGED IN A GOOD CONDITION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21465766 ↗
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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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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