ASAHI Gladius Mongo14 ES AP14R024SRecalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
All models of ASAHI Gladius Mongo14 ES (3)
Data updated Oct 16, 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 04547327123723), received between May 14, 2019 and May 14, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Device Embedded In Tissue or Plaque1
- Vessel Or Plaque, Device Embedded In1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF AN ASAHI GUIDE WIRE SEPARATED DURING A PCI TO TREAT A EXTREMELY TORTUOUS, SEVERELY CALCIFIED CTO IN THE PROXIMAL RCA. ACCORDING TO THE PHYSICIAN, THE EXISTING STENT HAD BEEN PLACED YEARS EARLIER AND WAS PROBABLY FRACTURED. ATTEMPTS WERE MADE WITH SEVERAL WIRES WITH A 2.0 BALLOON FOR SUPPORT; HOWEVER, ALL MET WITH NO SUCCESS. WHILE USING THE ASAHI GUIDE WIRE, IT WAS PROLAPSED BUT WAS SUBLUMINAL. WITH THE TORTUOSITY, THE HEAVY CALCIFICATION AND THE EXISTING STENT, THE RADIOPAQUE PORTION OF THE WIRE BROKE OFF AND WAS LEFT IN THE SUBINTIMAL SPACE. THE PIECE OF WIRE THAT WAS LEFT IN THE SUBINTIMAL SPACE WAS NOT MOVING AND ACCORDING TO THE PHYSICIAN, POSED NO THREAT TO THE PATIENT. A NEW NON-ASAHI WIRE WAS USED SUBSEQUENTLY WITH NO SUCCESS IN CROSSING AND THE CASE FINISHED.
Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In
MAUDE report 8606569 ↗
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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