ASAHI SION blue AHW14R104JRecalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
All models of ASAHI SION blue (5)
Data updated Oct 18, 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 04547327133029), received between Sep 17, 2025 and Sep 17, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Separation” (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.
Reports received per month
Most reported problems
Device problems
- Material Separation1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 17, 2025Material Separation; Material Separation
IT WAS REPORTED THAT A PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN ASAHI SION BLUE GUIDE WIRE WAS ADVANCED TO THE DISTAL LAD, WHILE A SECOND ASAHI SION BLUE GUIDE WIRE WAS ADVANCED TO THE LEFT CIRCUMFLEX ARTERY (LCX). A 2.5X12MM ONYX STENT (MEDTRONIC) WAS PLACED IN THE OBTUSE MARGINAL BRANCH (OM) AND BALLOON DILATATION WAS PERFORMED. AN ADDITIONAL 3.0X8MM ONYX STENT WAS DEPLOYED TO THE PROXIMAL OM. A 3.5X15MM XIENCE DRUG ELUTING STENT (DES) (ABBOTT) WAS DEPLOYED IN THE LAD, AND BALLOON DILATATION WAS PERFORMED. WHEN AN ATTEMPT WAS MADE TO REMOVE THE TWO SION BLUE GUIDE WIRES SIMULTANEOUSLY IN ORDER TO RE-POSITION THE SUBJECT SION BLUE GUIDE WIRE THAT HAD BEEN ADVANCED IN THE LAD TOWARD THE LCX, THE SUBJECT SION BLUE GUIDE WIRE WAS CAUGHT AND THE WIRE TIP WAS DETACHED. THE GUIDE WIRE WAS REPLACED WITH A DIFFERENT ONE AND RE-POSITIONED IN THE LAD. TWO BALLOON CATHETERS WERE USED FOR DILATATION TO SUCCESSFULLY REOPEN THE STENT. THE FINAL STENT OPTIMIZATION WAS PERFORMED WITH POST-DILATATION WITH AN UNIDENTIFIED BALLOON CATHETER. THE MID LAD LESION WAS NOT TREATED. THE PHY
Patient problems: Foreign Body In Patient
MAUDE report 23070614 ↗
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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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