ASAHI Gaia Third AHW14R311PRecalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547327094795), received between Oct 21, 2022 and Oct 30, 2022 — classified as 1 injury, 1 malfunction.
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 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Separation1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 30, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF AN ASAHI GAIA THIRD GUIDE WIRE SEPARATED DURING A PERCUTANEOUS CORONARY INTERVENTION TO TREAT A MILDLY CALCIFIED, MODERATELY TORTUOUS, CHRONIC TOTAL OCCLUSION (CTO) IN THE OBTUSE MARGINAL BRANCH (OM). THE TIP DETACHED WHILE ATTEMPTING TO CROSS CTO OF OM. THE TIP BECAME STUCK BEHIND THE STRUT OF AN EXISTING STENT IN OM AND DETACHED. THE TIP REMAINED IN THE PATIENT. SNARING WAS DISCUSSED BUT THE PHYSICIAN FELT THAT IT WOULD NOT BE POSSIBLE TO RETRIEVE THE TIP SINCE IT WAS UNDER THE STENT STRUT. THE PROCEDURE WAS COMPLETED USING THE STAR TECHNIQUE. THE PATIENT WAS DISCHARGED AFTER TREATMENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 15697545 ↗MalfunctionOct 21, 2022Material Separation; Material Separation
TIP OF GAIA THIRD SEPARATED AND DETACHED WHILE ATTEMPTING TO CROSS CTO OF OM. THE TIP BECAME STUCK BEHIND A STENT STRUT AND DETACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15651805 ↗
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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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