ASAHI SASUKE SA145-33NRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04547327120197), received between Feb 8, 2022 and Oct 28, 2025 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE TIP OF THE SUBJECT SASUKE BROKE OFF DURING A PLAIN OLD BALLOON ANGIOPLASTY (POBA) FOR A SEVERELY FLEXUOUS AND HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE DISTAL RIGHT CORONARY ARTERY (RCA). ALTHOUGH ATTEMPTS TO REMOVE THE TIP FRAGMENT WAS MADE, THE PHYSICIAN DECIDED TO LEAVE THE FRAGMENT LEFT IN SITU. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS CAUSED BY THE REPORTED EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23399633 ↗
• MalfunctionOct 23, 2025Material Fragmentation; Material Fragmentation

  VERY COMPLEX CASE; USING SASUKE AT THE PDA. TIP BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23373264 ↗
• InjuryOct 17, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ASAHI SASUKE DOUBLE LUMEN CATHETER WAS USED TO ACCESS FROM THE LEFT CIRCUMFLEX ARTERY (LCX) TO THE OBTUSE MARGINAL (OM) 1 TO TREAT A MILDLY CALCIFIED 75-90% STENOSED LESION IN THE MID LCX. WHEN ATTEMPTS WERE MADE TO REMOVE THE SASUKE CATHETER BY WAY OF BALLOON TRAPPING, A DISTAL SEGMENT OF THE CATHETER WAS RUPTURED IN THE CONCOMITANTLY USED GUIDING CATHETER. THE CATHETER DAMAGE WAS NOT RECOGNIZED UNTIL THE PHYSICIAN ADVANCED A BALLOON CATHETER THROUGH THE GUIDING CATHETER INTO THE LCX. THE SASUKE CATHETER FRAGMENT WENT INTO THE LCX. TWO UNSPECIFIED GUIDE WIRES WERE TWISTED TO SUCCESSFULLY TRAP AND REMOVE THE CATHETER FRAGMENT EX SITU. IT WAS INFORMED THAT THE PROCEDURE WAS CONTINUED AS USUAL WITHOUT ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS CAUSED BY THE REPORTED EVENT, AND THE PATIENT WAS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320057 ↗
• InjuryOct 15, 2025Break; Material Fragmentation; Break; Material Fragmentation

  THE PHYSICIAN USED SASUKE FOR OM1 ACCESS FROM THE CIRCUMFLEX. WHILE TRAPPING OUT THE DUAL LUMEN CATHETER, THE DISTAL PORTION OF THE SASUKE CATHETER SNAPPED INSIDE OF THE GUIDE CATHETER. THIS WAS NOT CLEAR UNTIL THE PHYSICIAN ADVANCED A BALLOON THROUGH THE GUIDE CATHETER AND INTO THE CIRCUMFLEX, WHICH CAUSED THE BROKEN-OFF PIECE OF THE SASUKE TO FALL INTO THE CIRCUMFLEX. THERE WERE NO ADVERSE EVENTS FROM THE PIECE OF THE SASUKE CATHETER. THE PATIENT WAS FINE AND THE CASE PROCEEDED AS NORMAL. THE BROKEN-OFF PIECE OF THE SASUKE WAS RETRIEVED USING TWO DIFFERENT WIRES AND TWISTING THEM UNTIL THEY TRAPPED THE PIECE AND IT WAS ABLE TO BE PULLED INTO THE GUIDE CATHETER AND TRAPPED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23305093 ↗
• InjuryFeb 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED WITH AN ASAHI SASUKE DOUBLE LUMEN CATHETER TO TREAT A MODERATELY TORTUOUS AND HEAVILY CALCIFIED BIFURCATION LESION IN THE DISTAL RIGHT CORONARY ARTERY (RCA). DURING MANIPULATION OF AN UNSPECIFIED GUIDE WIRE AT THE BIFURCATION SEGMENT, THE TIP SEGMENT OF THE SUBJECT SASUKE DOUBLE LUMEN CATHETER WAS CAUGHT AND DETACHED. THE WIRE FRAGMENT WAS LEFT IN THE RCA, WHICH WAS STENTED BY AN UNSPECIFIED STENT. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS DUE TO THE REPORTED EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21370527 ↗
• MalfunctionJan 31, 2025Material Fragmentation; Material Fragmentation

  WHILE WORKING ON WIRING THE DISTAL BIFURCATION OF THE RCA; SASUKE TIP BECAME ENTRAPPED AND SEPARATED FROM BODY OF CATHETER. TIP WAS LEFT IN RCA AND TRAPPED BEHIND A STENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289021 ↗
• InjuryFeb 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI SASUKE DOUBLE LUMEN CATHETER HAD SEPARATED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A MODERATELY TORTUOUS, ECCENTRICALLY CALCIFIED, 99% STENOSIS (30MM) IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A NON-ASAHI 6 FR MACH 1 FCL GUIDE CATHETER WAS ENGAGED. A NON-ASAHI RUNTHROUGH GUIDE WIRE WAS DELIVERED TO THE LAD, AND AN ASAHI PROWATER GUIDE WIRE WAS DELIVERED TO THE DIAGONAL BRANCH, AND ANOTHER RUNTHROUGH WAS DELIVERED TO THE CIRCUMFLEX ARTERY FOR PROTECTION. ONCE PROWATER WAS PLACED IN THE DIAGONAL BRANCH, SASUKE WAS TRAPPED OUT WITH DIFFICULTY. RESISTANCE WAS MET DURING REMOVAL. AFTER COMING OUT, THE PHYSICIAN REALIZED ON FLUOROSCOPY THAT PART OF THE CATHETER TIP WAS DISLODGED AND REMAINED IN THE MAIN VESSEL WIRE. A 1.5MM UNSPECIFIED BALLOON WAS USED TO PUSH THE TIP FRAGMENT FURTHER DOWN THE PERIPHERAL LAD. THE PATIENT WAS FINE WITHOUT ISSUE AFTER THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13539638 ↗
• InjuryFeb 8, 2022Break; Difficult to Remove

  LAST WEEK I HAD AN ISSUE WITH THE SASUKE MICROCATHETER. WE HAD SOME DIFFICULTY TAKING THE CATHETER OUT ONCE THE SIDE WIRE WAS DELIVERED. AFTER COMING OUT, WE REALIZED ON FLUOROSCOPY THAT PART OF THE CATHETER TIP WAS DISLODGED AND REMAINED IN THE MAIN VESSEL WIRE. AFTER WE COMPLETED THE PCI, THE PIECE OF THE CATHETER HAD ADVANCED MORE INTO DISTAL LAD. WE THEN DECIDED TO WIRE A DISTAL BRANCH OF THE LAD AND WE PUSHED THIS PIECE DOWN. DURING A PCI OF THE LAD -USE OF SASUKE DUAL LUMEN CATHETER. UPON REMOVAL OF THE SASUKE NOTICED DISTAL TIP BROKE OFF, STILL IN PATIENT, MD PUSHED IT FURTHER DOWN LAD AND LEFT IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13489022 ↗