ASAHI Gladius18 PPW18R300SRecalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547327106726), received between Dec 23, 2020 and Sep 2, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
- Material Fragmentation1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 2, 2025Material Separation; Material Separation
IT WAS REPORTED THAT AN ANGIOGRAPHY WAS PERFORMED FOR A MILDLY TORTUOUS, HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE MID POPLITEAL ARTERY. AN ASAHI GLADIUS GUIDE WIRE HAD FRACTURED DURING MANIPULATION. THE WIRE FRAGMENT WAS RETRIEVED WITH A SNARE. IT WAS INFORMED THAT THE PATIENT WAS FINE AFTER THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22931493 ↗MalfunctionAug 21, 2025Break; Material Fragmentation; Break; Material Fragmentation
GUIDE WIRE BROKE INSIDE THE PATIENT AND THE PIECE WAS RETRIEVED WITH A SNARE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22866481 ↗InjuryDec 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF AN ASAHI GLADIUS 18 GUIDE WIRE CAME OFF DURING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). THE GUIDE WIRE WAS USED WITH A NON-ASAHI TRAILBLAZER SUPPORT CATHETER DURING THE PROCEDURE. THE SEPARATED TIP WAS SNARED AND NOTHING WAS LEFT IN THE PATIENT. THE PATIENT WAS SUBSEQUENTLY DISCHARGED WITHOUT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11061913 ↗
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- 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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