Astato XS 20 PAGH143092Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547327088251), received between Jun 10, 2019 and Jul 29, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
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
- Break3
- Material Frayed2
Patient problems
- No Known Impact Or Consequence To Patient2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2019Break; Material Frayed
AFTER REMOVING THE GUIDE WIRE FROM THE PT'S ARTERY, WE NOTICED THE WIRE WAS FRAYED AND THE TIP APPEARED TO BE BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8839481 ↗MalfunctionJul 11, 2019Break; Break
IT WAS REPORTED BY SUS VOLUNTARY EVENT REPORT # MW5087261 THAT AN ASAHI GUIDE WIRE WAS USED IN INTERVENTION. AFTER REMOVING THE GUIDE WIRE FROM THE PATIENT'S ARTERY, IT WAS NOTICED THE WIRE WAS FRAYED AND THE TIP APPEARED TO BE BROKEN. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Information
MAUDE report 8783379 ↗MalfunctionJun 10, 2019Break; Material Frayed
AFTER REMOVING THE GUIDE WIRE FROM THE PT'S ARTERY, WE NOTICED THE WIRE WAS FRAYED AND THE TIP APPEARED TO BE BROKEN. FDA SAFETY REPORT ID# (B)(4).
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8687820 ↗
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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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