MIRACLEBROS 12 AG14M370Recalls & 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 04547327058148), received between Dec 14, 2021 and Dec 19, 2021 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF AN ASAHI MIRACLEBROS 12 GUIDE WIRE HAD BROKE OFF DURING AN INTERVENTION TO TREAT A HEAVILY CALCIFIED, 90% STENOSIS IN THE PROXIMAL THIRD OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE GUIDE WIRE WAS ADVANCED AND GOT LODGED OR STUCK IN HEAVY CALCIUM. THE PHYSICIAN TORQUED THE GUIDE WIRE TO RELEASE IT FROM CALCIUM WHEN THE TIP BROKE. THE SEPARATED TIP WAS VISIBLE AND WAS SUBSEQUENTLY STENTED IN THE WALL OF THE VESSEL AT THE LESION. THERE WAS NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS DISCHARGED AFTER TREATMENT.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 13041096 ↗MalfunctionDec 14, 2021Break
THE INFORMATION THAT WAS SHARED TO ME WAS THAT THE TIP BROKE OFF AFTER GETTING LODGED/STUCK IN HEAVY CALCIUM. THE TIP WAS VISIBLE AND WAS SUBSEQUENTLY STENTED IN THE WALL OF THE VESSEL AT THE LESION.
Patient problems: Foreign Body In Patient
MAUDE report 13004557 ↗
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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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