SOFT AG141300Recalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04547327056229), received between Jul 12, 2022 and Oct 5, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (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 16, 2026.
Most reported problems
Device problems
- Fracture3
- Entrapment of Device1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 5, 2022Fracture; Stretched; Fracture; Stretched
IT WAS REPORTED THAT THE TIP OF AN ASAHI SOFT GUIDE WIRE BECAME FRACTURED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90-99% STENOSIS IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE GUIDE WIRE WAS REMOVED AND EXCHANGE TO A SECOND SOFT. THE PCI WAS COMPLETED WITH SUCCESS. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15547722 ↗MalfunctionSep 24, 2022Fracture; Fracture
WIRE TIP BECAME FRACTURED IN CASE AND HAD TO REMOVE AND EXCHANGE WIRE. USED A SECOND SOFT WITH SUCCESS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15479651 ↗MalfunctionJul 12, 2022Entrapment of Device
FIRST TWO SOFT WIRES USED BOTH WITH THE SAME LOT NUMBER EXPERIENCED A DISTAL CORE FRACTURE OBSERVED ON X-RAY. A THIRD SOFT WIRE WAS USED BUT FROM A DIFFERENT LOT NUMBER. IT WAS FINE. PATIENT OUTCOME WAS GOOD.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 14991043 ↗MalfunctionJul 12, 2022Fracture
FIRST TWO SOFT WIRES USED BOTH WITH THE SAME LOT NUMBER EXPERIENCED A DISTAL CORE FRACTURE OBSERVED ON X-RAY. A THIRD SOFT WIRE WAS USED BUT FROM A DIFFERENT LOT NUMBER. IT WAS FINE. PATIENT OUTCOME WAS GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14990022 ↗
Other WIRE, GUIDE, CATHETER devices
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- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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