ASAHI SION black APW14R310SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04547327089708), received between May 21, 2021 and Jun 4, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 4, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE TIP OF AN ASAHI SION BLACK GUIDE WIRE HAD SEPARATED DURING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) TO TREAT THE MILDLY TORTUOUS, MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). THE SION BLACK GUIDE WIRE WAS ADVANCED TO CROSS AN OCCLUDED STENT IN THE SFA AND WAS DELIVERED TO THE TARGET SEGMENT THROUGH THE STENT STRUT. AN UNSPECIFIED BALLOON WAS ABLE TO BE INFLATED. UPON REMOVAL OF THE SION BLACK GUIDE WIRE, THE WIRE TIP APPEARED TO HAVE SHEARED OFF. THE WIRE FRAGMENT REMAINED IN THE PATIENT ANATOMY AND THE PHYSICIAN DETERMINED TO FOLLOW-UP MONITOR THE PATIENT. THE PATIENT WAS DISCHARGED AND SENT HOME AFTER A FEW HOURS OF BEDREST. THE PHYSICIAN COMMENTED THAT IT WAS SPECULATED EARLIER IN THE CASE THAT THE GUIDE WIRE MAY HAVE BEEN ADVANCED THROUGH A STENT STRUT BECAUSE RESISTANCE WAS FELT DURING ADVANCEMENT OF THE CONCOMITANT CATHETER. IT WAS INFORMED THAT THE PATIENT WAS FINE WITHOUT ANY ISSUES AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22139053 ↗
• MalfunctionMay 16, 2025Material Fragmentation; Material Fragmentation

  DELIVERED THE WIRE WITH NO ISSUE THROUGH AN OCCLUDED SFA STENT. THERE IS A CHANCE THE WIRE WENT THROUGH A STENT STRUT BUT THE BALLOONS PASSED WITH NO ISSUE. UPON REMOVING THE WIRE, SHE NOTICED THE END HAD APPEARED TO HAVE SHEARED OFF. NO ADVERSE EFFECT TO PATIENT. ADDITIONAL INFORMATION: 1) IT WAS SPECULATED EARLIER IN THE CASE THAT THE WIRE MAY HAVE BEEN THROUGH A STENT STRUT BECAUSE A CATHETER COULDN'T ADVANCE PASSED A CERTAIN SPOT. A SMALL BALLOON WAS INFLATED AND THEN THERE WAS NO ISSUE MOVING FORWARD. MD DID NOT MENTION ANY RESISTANCE TO THE WIRE UPON REMOVAL. 2) THE FRAGMENT THAT WAS SHEARED OFF FROM THE WIRE WAS NOT RETRIEVED FROM THE BODY 3) THE PROCEDURE WAS FINISHED AS PLANNED AND WAS A SUCCESS. 4) THE PROCEDURE WAS DONE WITH SUCCESS IN AN OBL. I BELIEVE THE PATIENT WAS SENT HOME AFTER A FEW HOURS OF BEDREST.

  Patient problems: Foreign Body In Patient

  MAUDE report 22040357 ↗
• InjuryJun 4, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN INTERVENTION WAS PERFORMED TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED 90-99% STENOSIS IN THE ANTERIOR TIBIAL ARTERY (ATA). AN ASAHI SION BLACK GUIDE WIRE HAD BEEN USED TO NAVIGATE DOWN THE ATA DISTAL TO THE FOOT AND PERFORMED WELL UNTIL IT WAS BEING REMOVED. THE SION BLACK WAS BEING REMOVED WITH A NON-ASAHI NAVICROSS .014" 150CM CURVED TIP AND BECAME STUCK NEAR THE HUB, THEY SWAPPED THE .014" NAVICROSS FOR AN .018" 150CM NAVICROSS AND DEVICE WAS STILL NOT EASILY ABLE TO BE REMOVED. ONCE THE SION BLACK WAS REMOVED FROM THE ANATOMY IT WAS EXAMINED AND THE COATING HAD BEEN COMPROMISED AND APPEARED TO HAVE BEEN STRIPPED DOWN THE METAL IN AN ACCORDION FASHION IN THE DISTAL 10-30CM AREA. THEY WERE ABLE TO ANGIOGRAPHICALLY CONFIRM THAT NO COATING WAS LEFT IN THE ANATOMY AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11937037 ↗
• MalfunctionMay 21, 2021Peeled/Delaminated; Difficult to Remove; Physical Resistance/Sticking

  SION BLACK HAD BEEN USED TO NAVIGATE DOWN THE AT DISTAL TO THE FOOT AND PERFORMED WELL UNTIL IT WAS BEING REMOVED. THE SION BLACK WAS BEING REMOVED WITH A NAVICROSS .014" 150CM CURVED TIP AND BECAME STUCK NEAR THE HUB, THEY SWAPPED THE .014" NAVI FOR AN .018" 150CM NAVICROSS AND DEVICE WAS STILL NOT EASILY ABLE TO BE REMOVED. ONCE THE SION BLACK WAS REMOVED FROM THE ANATOMY IT WAS EXAMINED AND THE COATING HAD BEEN COMPROMISED AND APPEARED TO HAVE BEEN STRIPPED DOWN THE METAL IN AN ACCORDION FASHION IN THE DISTAL 10-30CM AREA. THEY WERE ABLE TO ANGIOGRAPHICALLY CONFIRM THAT NO COATING WAS LEFT IN THE ANATOMY AND THERE WAS NO HARM TOT HE PATIENT. THEY DO HAVE THE SAMPLE OF THE DEVICE THAT I WILL BE PICKING UP AND SENDING IN NEXT TUESDAY, AS WELL AS A COUPLE PICTURE THAT I HAVE ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11864132 ↗