FIELDER XT-A APW14R009SRecalls & 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 04547327088121), received between Oct 10, 2019 and Oct 28, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unraveled Material” (2 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
- Unraveled Material2
- Flaked1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 28, 2019Flaked; Unraveled Material; Flaked; Unraveled Material
IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED TO TREAT A SEVERELY CALCIFIED CTO IN THE MID RIGHT CORONARY ARTERY (RCA). A DISSECTION / RE-ENTRY TECHNIQUE WAS USED TO TRY AND TAKE THE ASAHI FIELDER XT-A GUIDE WIRE FROM THE SUBINTIMAL SPACE BACK INTO THE TRUE LUMEN OF THE ARTERY. DURING THE RE-ENTRY, THE GUIDE WIRE CAUGHT ON CALCIUM AND THE COILS AT THE TIP OF THE GUIDE WIRE UNWOUND. THE WIRE WAS REMOVED IN ITS ENTIRETY AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9247971 ↗MalfunctionOct 10, 2019Unraveled Material
THE MID RCA WAS HEAVILY CALCIFIED AND A DISSECTION / RE-ENTRY TECHNIQUE WAS USED TO TRY AND TAKE THE XTA FROM THE SUBINTIMAL SPACE BACK INTO THE TRUE LUMEN OF THE ARTERY. DURING THE RE-ENTRY THE WIRE CAUGHT ON CALCIUM AND THE COILS AT THE TIP OF THE XTA UNWOUND. THE WIRE WAS REMOVED IN ITS ENTIRETY AND THERE WAS NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9176995 ↗
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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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