ASAHI Gladius14 PPW14R300SRecalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
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 04547327106665), received between Feb 15, 2018 and Feb 15, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Peeled/Delaminated” (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.
Most reported problems
Device problems
- Peeled/Delaminated1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 15, 2018Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT THE POLYMER JACKET OF THE SUBJECT GUIDE WIRE WAS FOUND PEELED OFF DURING A PCI TO TREAT A MILDLY CIRCUMFLEX AND HEAVILY CALCIFIED TOTAL OCCLUSION IN THE TIBIAL ARTERY. IPSILATERAL RIGHT SIDE APPROACH WAS TAKEN AGAINST THE AT OCCLUSION. AFTER THE SUBJECT GUIDE WIRE CROSSED THE OCCLUSION BEAUTIFULLY, THE PHYSICIAN INTENTIONALLY DID NOT EXCHANGE THE GUIDE WIRE TO AN ATHERECTOMY WIRE AND ATHERECTOMY DEVICE WAS PLACED OVER THE SUBJECT GUIDE WIRE AND SPUN FOR A LONG TIME SINCE THE VESSEL WAS VERY CALCIFIED. THE PHYSICIAN WAS AWARE THAT THE GUIDE WIRE HAD A POLYMER JACKET AND HYDROPHILLIC COATING. ATHERECTOMY WENT WELL AND THE PHYSICIAN DECIDED TO BALLOONING. AFTER BALLOON WAS INFLATED MULTIPLE TIMES, AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE FROM THE BALLOON CATHETER. IT SEEMED THE DEVICES WERE STUCK ON ONE ANOTHER. THEN THE PHYSICIAN REMOVED EVERYTHING FROM THE PATIENT ALTOGETHER (BALLOON AND WIRE) AND GOT THE GUIDE WIRE BACK THROUGH THE BALLOON WITH EFFORT. WHEN THE GUIDE WIRE WAS FINALLY PULLED OUT OF THE BALLOON CATHETER, IT WAS NOTICED THAT PART OF THE POLYMER JACKET HAD SHEARED OFF. POST RUN WAS COMPLETED; NO DISTAL EMBOLIZATION OR MATERIAL WAS FOUND IN PATI
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7275927 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
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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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