ASAHI SION blue AHW14R304SRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04547327086233), received between Jul 2, 2021 and Jul 16, 2021 — classified as 2 injuries.
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
- Fracture1
Patient problems
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
UF REPORT #: (B)(4) WAS RECEIVED FROM THE US IMPORTER. IT WAS REPORTED AS FOLLOWS: PHYSICIAN WAS PERFORMING A CARDIAC PROCEDURE WITH A GUIDEWIRE THAT WAS INSERTED TO BALLOON A CORONARY ARTERY (TARGET WAS A CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY). UPON REMOVAL OF THE GUIDEWIRE, IT WAS NOTED THAT A TIP OF THE WIRE HAD FRACTURED AND A SMALL PIECE WAS LEFT IN THE ARTERY PER PHYSICIAN INSTRUCTIONS. THE TIP WAS UNFORTUNATELY NOT RETRIEVED DUE TO POTENTIAL FURTHER COMPLICATIONS. THE PROCEDURE WAS COMPLETED; HOWEVER, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER EVALUATION AND OBSERVATION DUE TO THE FRACTURED TIP AND DUE TO POTENTIAL THROMBOSIS. ALTHOUGH THE TIP WAS NOT REMOVED, THE PATIENT HAS SINCE RECOVERED AND FOLLOWS UP WITH THE PHYSICIAN MONTHLY.
Patient problems: Foreign Body In Patient
MAUDE report 12178929 ↗InjuryJul 2, 2021Fracture
PHYSICIAN WAS PERFORMING A CARDIAC PROCEDURE WITH A GUIDEWIRE THAT WAS INSERTED TO BALLOON A CORONARY ARTERY. UPON REMOVAL OF THE GUIDEWIRE, IT WAS NOTED THAT A TIP OF THE WIRE HAD FRACTURED AND A SMALL PIECE WAS LEFT IN THE ARTERY PER PHYSICIAN INSTRUCTIONS. 07/01/2021 PHONE CORRESPONDENCE FROM THE REPORTER (B)(6): "THE DOCTOR WAS ABLE TO RETRIEVE THE TIP AND IT WAS NOT LEFT IN THE PATIENT".
Patient problems: Insufficient Information
MAUDE report 12110172 ↗
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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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