ASAHI SION black APW14R010SRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04547327089685), received between Aug 16, 2021 and Nov 20, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Fracture; Difficult to Remove

  THE TIP OF THE GUIDEWIRE FRACTURED OFF AND WAS UNABLE TO BE RETRIEVED.

  Patient problems: Insufficient Information

  MAUDE report 23604344 ↗
• InjuryNov 6, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ASAHI SION BLACK GUIDE WIRE WAS USED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A HEAVILY TORTUOUS AND MILDLY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT CIRCUMFLEX ARTERY (LCX) AND THE OTHER CTO IN THE RIGHT CORONARY ARTERY (RCA) BY WAY OF THE RETROGRADE APPROACH. DURING WIRING THROUGH A SEPTAL BRANCH, THE DISTAL SEGMENT OF THE GUIDE WIRE WAS UNRAVELED, LEAVING A FRAGMENT IN THE SEPTAL BRANCH. THE LCX LESION WAS SUCCESSFULLY CROSSED AND BALLOONED, WHILE THE RCA LESION WAS ALSO SUCCESSFULLY CROSSED AND STENTED. BLOOD FLOW WAS REESTABLISHED AND THE PROCEDURE WAS COMPLETED. IT WAS INFORMED THAT THE PATIENT WAS DOING FINE AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20616453 ↗
• MalfunctionOct 31, 2024Fracture; Unraveled Material; Fracture; Unraveled Material

  WIRING THROUGH A SEPTAL BRANCH, THE SION BLACK TIP UNRAVELED AND LEFT A PIECE DISTAL IN THE SEPTAL BRANCH. PATIENT WAS OK AND RIGHT WAS CROSSED AND STENTED. PIECE LEFT IN DISTAL SEPTAL BRANCH.

  Patient problems: Foreign Body In Patient

  MAUDE report 20584404 ↗
• MalfunctionSep 1, 2021Detachment of Device or Device Component

  WIRE TIP CAME OFF WHILE NAVIGATING STENT STRUTS. MANUFACTURER RESPONSE FOR WIRE, GUIDE, CATHETER, ASAHI SION BLACK (PER SITE REPORTER). GOOD FOLLOW-UP.

  Patient problems: Insufficient Information

  MAUDE report 12405438 ↗
• InjuryAug 27, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI SION BLACK GUIDE WIRE BROKE OFF DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT CIRCUMFLEX ARTERY (LCX). A STENT WAS DEPLOYED INTO THE LEFT MAIN TRUNK (LMT) TO THE LCX. THEN, THE SION BLACK WAS USED TO WIRE THROUGH THE STENT TO DILATE THE STENT STRUTS AND FURTHER SUPPORT NORMAL BLOOD FLOW THROUGH STENT INTO LCX. THE SION BLACK NAVIGATED THE STENT STRUTS AND WAS GUIDED DOWN THE LCX FOR AN UNKNOWN DISTANCE. A RX CORONARY BALLOON WAS ADVANCED OVER THE SION BLACK WITH THE PLAN TO PASS THROUGH THE STRUTS AND DILATE THE OSTIUM. THE BALLOON WOULD NOT CROSS THE STRUTS AND WAS REMOVED. IT IS UNKNOWN IF THE BALLOON WAS INFLATED AT ANY TIME. AN ATTEMPT WAS THEN MADE TO REMOVE THE SION BLACK BUT IT WAS STUCK IN THE LCX. FORCE WAS USED AND THE DISTAL WIRE SEPARATED FROM THE BODY AT THE JUNCTION OF THE RADIOPAQUE TO THE BODY OF THE WIRE. THE PHYSICIAN COMMENTED THAT THE A CARDIAC INTERVENTIONAL FELLOW, WHO HAS JUST STARTED THEIR FOURTH YEAR/HANDS-ON, WAS DOING THE WIRING OF THE LCX AND MIGHT HAVE "STITCHED" THE WIRE IN AND OUT OF STENT OPENINGS BEFORE ENTERING THE LCX. WHEN THE PHYSICIAN WENT TO RETRI

  Patient problems: Foreign Body In Patient

  MAUDE report 12376236 ↗
• InjuryAug 16, 2021Material Separation; Physical Resistance/Sticking

  THESE ARE THE EVENTS AS THEY WERE PROVIDED TO THE SALES REP. SALES REP WAS NOT PRESENT DURING THIS EVENT. THE SION BLACK WAS USED TO WIRE THROUGH FRESHLY PLACED LEFT MAIN STENT INTO THE LCX. THE GOAL WAS TO DILATE THE STENT STRUTS AND FURTHER SUPPORT NORMAL BLOOD FLOW THROUGH STENT INTO LCX. THE LCX WAS A CTO AT THE BEGINNING OF THE PROCEDURE. SALES REP DOES NOT KNOW IF THIS WAS A NEW WIRE OR IF IT HAD BEEN USED EARLIER IN THE PROCEDURE. SALES REP DOES NOT KNOW THE STATE OF THE LCX AFTER REVASCULARIZATION OR IF ANY STENTING THAT MAY HAVE BEEN DONE. THE SION BLACK NAVIGATED THE STENT STRUTS AND WAS GUIDED DOWN THE LCX FOR AN UNKNOWN DISTANCE. A RX CORONARY BALLOON WAS ADVANCED OVER THE SION BLACK WITH THE PLAN TO PASS THROUGH THE STRUTS AND DILATE THE OSTIUM. THE BALLOON WOULD NOT CROSS THE STRUTS AND WAS REMOVED, SALES REP DOES NOT HAVE INFORMATION IF IT WAS INFLATED AT ANY TIME. AN ATTEMPT WAS THEN MADE TO REMOVE THE SION BLACK BUT IT WAS STUCK IN THE LCX. FORCE WAS USED AND THE DISTAL WIRE SEPARATED FROM THE BODY AT THE JUNCTION OF THE RADIOPAQUE TO THE BODY OF THE WIRE. ATTEMPTS WERE MADE TO RETRIEVE THE DISTAL END OF THE WIRE USING A MICRO SNARE BUT THEY WERE UNSUCCESSFUL. FURT

  Patient problems: Insufficient Information

  MAUDE report 12329142 ↗