MIRACLEBROS 12 AG14M070Recalls & reported problems
Asahi Intecc CO., Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04547327058131), received between Oct 17, 2019 and Nov 11, 2019 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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
- Activation, Positioning or Separation Problem1
- Detachment of Device or Device Component1
- Difficult to Remove1
- Material Fragmentation1
- Physical Resistance/Sticking1
Patient problems
- Device Embedded In Tissue or Plaque3
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
UF REPORT #: (B)(4) WAS RECEIVED FROM THE US IMPORTER ON OCTOBER 24,, 2019. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CARDIAC CATHETERIZATION FOR AN RCA PCI. MULTIPLE ATTEMPTS WERE MADE TO OPEN THE BLOCKAGE. DURING THIS PROCESS, A WIRE WAS UNABLE TO BE REMOVED FOR THE RCA. MULTIPLE SNARES WERE DEPLOYED TO REMOVE THE WIRE, HOWEVER EACH ATTEMPT UNSUCCESSFUL. FINALLY A RADIAL JAW WAS USE TO PULL THE WIRE. WIRE BROKE AND WAS REMOVED FROM THE PATIENT'S RADIAL ARTERY. A FRAGMENT OF THE WIRE REMAINS IN THE PATIENT'S RCA. NO PATIENT HARM NOTED.
Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient
MAUDE report 9307291 ↗InjuryOct 28, 2019Material Fragmentation; Difficult to Remove
PATIENT UNDERWENT A CARDIAC CATHETERIZATION FOR AN RCA PCI. MULTIPLE ATTEMPTS WERE MADE TO OPEN THE BLOCKAGE. DURING THIS PROCESS, A WIRE WAS UNABLE TO BE REMOVED FOR THE RCA. MULTIPLE SNARES WERE DEPLOYED TO REMOVE THE WIRE, HOWEVER EACH ATTEMPT UNSUCCESSFUL. FINALLY A RADIAL JAW WAS USE TO PULL THE WIRE. WIRE BROKE AND WAS REMOVED FROM THE PATIENT'S RADIAL ARTERY. A FRAGMENT OF THE WIRE REMAINS IN THE PATIENT'S RCA.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9246852 ↗MalfunctionOct 17, 2019Activation, Positioning or Separation Problem; Physical Resistance/Sticking
PATIENT UNDERWENT A CARDIAC CATHETERIZATION FOR AN RCA PCI. MULTIPLE ATTEMPTS WERE MADE TO OPEN THE BLOCKAGE. DURING THIS PROCESS, A WIRE WAS UNABLE TO BE REMOVED FOR THE RCA. MULTIPLE SNARES WERE DEPLOYED TO REMOVE THE WIRE, HOWEVER EACH ATTEMPT UNSUCCESSFUL. FINALLY A RADIAL JAW WAS USE TO PULL THE WIRE. WIRE BROKE AND WAS REMOVED FROM THE PATIENT'S RADIAL ARTERY. A FRAGMENT OF THE WIRE REMAINS IN THE PATIENT'S RCA.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9202192 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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