ASAHI Corsair Pro XS CSR150-21SRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04547327123679), received between Aug 19, 2020 and Dec 23, 2025 — classified as 1 death, 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A CHRONIC TOTAL OCCLUSION (CTO) IN THE SEVERELY FIBROTIC AND HEAVILY CALCIFIED LEFT CIRCUMFLEX CORONARY ARTERY (LCX) WITH A Y-SHAPED ANASTOMOSIS OF VEIN GRAFT TIED IN. AN ASAHI SION BLUE GUIDE WIRE WAS ADVANCED TO THE ANASTOMOSIS OF VEIN GRAFT, FOLLOWED BY AN ASAHI CORSAIR PRO XS MICROCATHETER. WHEN THE CATHETER TIP REACHED THE ANASTOMOSIS, RESISTANCE WAS MET. THE PHYSICIAN TRIED TO ADVANCE THE MICROCATHETER BY TORQUEING FOR A VERY SHORT PERIOD OF TIME (LESS THAN 10 SECONDS), WHEN THE MICROCATHETERAND THE GUIDE WIRE FELT STUCK TO EACH OTHER. THE TWO DEVICES WERE REMOVED AS A UNIT. WHEN A DIFFERENT WORKHORSE GUIDE WIRE WAS ADVANCED TO THE ANASTOMOSIS OF VEIN GRAFT, SOME OBJECT WHICH LOOKED LIKE BALLOON RADIOPAQUE MARKERS WERE FOUND BETWEEN THE GRAFT MARKERS WERE OBSERVED FOR THE FIRST TIME UNDER ANGIOGRAPHY. WHEN THE REMOVED CORSAIR PRO XS MICROCATHETER AND SION BLUE GUIDE WIRE WERE EXAMINED, THE MICROCATHETER TIP APPEARED SLIGHTLY SHORTENED VISUALLY. UPON SLIGHT MANIPULATION OF THE TWO DEVICES, THE DISTAL TIP OF THE MICROCATHETER WAS FOUND LOOSENED. THE ANASTOMOSIS WAS PRE-DILATED, ANOTHER CORSAIR PRO

  Patient problems: Foreign Body In Patient

  MAUDE report 23874712 ↗
• InjuryDec 22, 2025Material Fragmentation; Physical Resistance/Sticking; Material Fragmentation; Physical Resistance/Sticking

  A SION BLUE WAS USED TO WIRE A VEIN GRAFT TIED IN TO THE LEFT CIRCUMFLEX. WHEN THE CORSAIR PRO XS WAS ADVANCED BEHIND THE WIRE, THERE WERE NO ISSUES UNTIL IT REACHED THE ANASTOMOSIS SITE AT THE TIP. AFTER MEETING RESISTANCE, WITHIN JUST A FEW SECONDS (<10S) OF TRYING TO TORQUE AND ADVANCE THE MICROCATHETER, THE OPERATOR COULD FEEL THAT IT HAD FUSED ONTO THE WIRE. ONCE THIS WAS REALIZED, THE WIRE AND MICROCATHETER WERE REMOVED AS A UNIT. THE MICROCATHETER WAS DISCARDED AND ANOTHER WORKHORSE WIRE WAS ADVANCED DOWN THE VEIN GRAFT. DURING THIS REWIRING UNDER LIVE FLUORO, WE NOTICED WHAT LOOKED LIKE BALLOON RADIOPAQUE MARKERS LOCATED BETWEEN THE GRAFT MARKERS THAT WEREN'T THERE BEFORE. PATIENT WAS UNDER ANESTHESIA WHEN EVENT OCCURRED AND WAS NOT AFFECTED BY THE PART OF THE DEVICE THAT WAS LEFT BEHIND IN THE VEIN GRAFT. THE PATIENT WAS ALSO HEMODYNAMICALLY STABLE BEFORE, DURING, AND AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23867401 ↗
• InjuryNov 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED FOR A MILDLY TORTUOUS AND MILDLY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN ASAHI CORSAIR PRO XS MICROCATHETER AND AN ASAHI SION GUIDE WIRE WERE ADVANCED TO THE SEPTAL CHANNEL THROUGH THE #4 POSTERIOR DESCENDING (PD) BRANCH VIA RETROGRADE APPROACH. THE SION GUIDE WIRE WAS EXCHANGED TO AN ASAHI SUOH 03 GUIDE WIRE AND THE SUOH 03 GUIDE WIRE COULD BE ADVANCED TO THE LAD. ALTHOUGH THE CORSAIR PRO XS MICROCATHETER COULD NOT BE ADVANCED AT FIRST, THE CORSAIR PRO XS MICROCATHETER COULD BE ADVANCED WITH THE SUPPORT OF A NIPRO 5FR GUIDE PLUS GUIDING CATHETER. USING THE RETROGRADE GUIDE WIRE AS A MARKER, AN ASAHI SASUKE DOUBLE LUMEN CATHETER AND AN ASAHI CONQUEST PRO 12 ST GUIDE WIRE WERE ADVANCED VIA ANTEGRADE APPROACH, BUT THEY COULD NOT CROSS THE LESION. THE GUIDE WIRE WAS CHANGED TO AN ASAHI GLADIUS GUIDE WIRE, TO AN ASAHI GAIA NEXT 4 GUIDE WIRE AND FINALLY TO AN ASAHI CONQUEST PRO 8-20 GUIDE WIRE. THE CONQUEST PRO 8-20 GUIDE WIRE CROSSED THE LESION. WHEN THE RETROGRADE SION GUIDE WIRE WAS REMOVED AFTER PERFORMING REVERSE CART TECHNIQUE, PERFORATION WAS OBSERVED IN

  Patient problems: Perforation of Vessels

  MAUDE report 23566081 ↗
• InjuryJan 14, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR A CHRONIC TOTAL OCCLUSION (CTO) LESION IN SEGMENTS #1-3 OF THE RIGHT CORONARY ARTERY (RCA) WAS PERFORMED BY THE RETROGRADE APPROACH WITH A FINECROSS MICROCATHETER (TERUMO) AND AN ASAHI SUOH 03 GUIDE WIRE BY WAY OF THE FIRST SEPTAL BRANCH. AS A STENT HAD BEEN ALREADY DEPLOYED, THE FINECROSS MICROCATHETER COULD NOT BE ADVANCED. AFTER AN UNSPECIFIED BALLOON CATHETER WAS INSERTED AND DILATED UP TO ITS RATED BURST PRESSURE (RBP), THE FINECROSS MICROCATHETER WAS REPLACED BY AN ASAHI CORSAIR PRO XS MICROCATHETER. ADVANCED OVER THE SUOH 03 GUIDE WIRE AND WENT THROUGH A STENT STRUT, THE ASAHI CORSAIR PRO XS MICROCATHETER WAS TRAPPED, AND APPROXIMATELY A THIRD OF THE TIP SEGMENT OF THE MICROCATHETER WAS LEFT IN THE PATIENT ANATOMY. A NEW ASAHI CORSAIR PRO XS MICROCATHETER WAS USED TO APPROACH FROM A DIFFERENT SEPTAL BRANCH WITH SUCCESS. AN UNSPECIFIED STENT WAS DEPLOYED IN THE TARGET LESION, AND THE PROCEDURE WAS COMPLETED. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS CAUSED BY THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21146910 ↗
• InjurySep 26, 2022Difficult to Remove; Material Split, Cut or Torn; Difficult to Remove; Material Split, Cut or Torn

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT A MODERATELY TORTUOUS, HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN SEGMENTS #2-3 OF THE RIGHT CORONARY ARTERY (RCA). AN ASAHI ULTIMATE BROS 3 GUIDE WIRE AND AN ASAHI CORSAIR PRO XS MICROCATHETER WERE USED FOR A RETROGRADE APPROACH VIA SEPTAL COLLATERAL. WHEN ADVANCING THE TWO DEVICES TO THE LESION IN SEGMENT #2, THE CORSAIR PRO XS BECAME STUCK IN THE LESION. ALTHOUGH THE ULTIMATE BROS 3 WAS ABLE TO BE REMOVED, DIFFICULTY WAS MET WHEN REMOVING THE CORSAIR PRO XS. AN ASAHI RG3 GUIDE WIRE WAS THEN ADVANCED RETROGRADELY FOR EXTERNALIZATION. WHEN ATTEMPTING TO REMOVE THE CORSAIR PRO XS, THE TRAPPED CORSAIR PRO XS WAS NOT RELEASED EVEN THOUGH THE CATHETER SHAFT BECAME ELONGATED. AN UNSPECIFIED GUIDE WIRE WAS THEN ADVANCED ANTEGRADELY CLOSE TO THE TIP OF THE CORSAIR PRO XS. A BALLOON CATHETER WAS ADVANCED AND INFLATED TO RELEASE THE TRAPPED CORSAIR PRO XS. AFTER REMOVING THE CORSAIR PRO XS, THE PROCEDURE WAS RESUMED AND SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW ACHIEVED BY STENTING. THERE WERE NO ADVERSE PATIENT EFFECTS RELATED TO THIS EVENT AND THE PATIENT WAS FINE WITHOUT COMPLICATIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15483339 ↗
• InjurySep 11, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ASAHI CORSAIR PRO XS MICROCATHETER AND AN ASAHI FIELDER XT-R GUIDE WIRE BECAME STUCK TO EACH OTHER DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN AN UNSPECIFIED SEGMENT OF THE CORONARY ARTERY. THE TWO DEVICES COULD NOT BE MANIPULATED AS INTENDED AND DIFFICULTY WAS MET IN REMOVAL. THE CONNECTOR OF THE CORSAIR PRO XS WAS CUT OFF AND AN UNSPECIFIED GUIDE EXTENSION CATHETER WAS USED TO REMOVE THE TWO DEVICES. THE PROCEDURE WAS THEN RESUMED AND SUCCESSFULLY COMPLETED WITH STENT DEPLOYMENT. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. CORSAIR PRO XS: MFR REPORT. FIELDER XT-R: MFR REPORT # 3003775027-2022-00106.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15398098 ↗
• InjuryJul 7, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) LESION IN THE PROXIMAL-MID LEFT ANTERIOR DESCENDING ARTERY (LAD). AN ASAHI CORSAIR PRO XS MICROCATHETER WAS USED FOR A RETROGRADE APPROACH FROM THE RIGHT CORONARY ARTERY (RCA) VIA A SEPTAL COLLATERAL AND PASSED THROUGH THE COLLATERAL CHANNEL WITHOUT PROBLEM. WHEN ADVANCING THE CORSAIR PRO XS ALONG WITH AN ASAHI ULTIMATEBROS 3 GUIDE WIRE, ANGIO IMAGES REVEALED THAT THE TIP OF THE CORSAIR PRO XS WAS DEFORMED. WHEN ATTEMPTS WERE MADE TO REMOVE THE CORSAIR PRO XS, IT WAS NOTED THAT THE MICROCATHETER WAS STUCK TO THE ULTIMATE BROS 3 AND THEREFORE BOTH OF THE DEVICES WERE REMOVED AS A UNIT. THE DEVICE WAS REPLACED TO RESUME THE PROCEDURE. THE PCI WAS SUCCESSFULLY COMPLETED WITH STENT DEPLOYMENT. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS REPORTEDLY FINE WITHOUT PROBLEM AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132726 ↗
• MalfunctionNov 6, 2020Material Separation

  ROTABLATOR CASE INITIALLY USED MAMBA CATHETER TO ATTEMPT TO CROSS LESION AND WAS UNSUCCESSFUL. USED CORSAIR XS TO CROSS THE TOOK ROTABLATOR WIRE DOWN LAD TO ROTABLATE VESSEL. WHEN TRYING TO EXCHANGE THE WIRE OVER THE CORSAIR XS AFTER ROTABLATING THE WIRE GOT STUCK AT THE TIP OF THE CATHETER. AT WHICH POINT PHYSICIAN PULLED BOTH CATHETER AND WIRE OUT TOGETHER. EXAMINATION OF THE TIP OF THE CATHETER SHOWED DAMAGE WITH TIP SEPARATION.

  Patient problems: Insufficient Information

  MAUDE report 10797652 ↗
• InjuryNov 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CORSAIR PRO XS MICROCATHETER SEPARATED DURING A PCI TO TREAT A CTO IN THE CORONARY ARTERY. THE CATHETER WAS CROSSING A SEPTAL CHANNEL WHEN IT GOT STUCK IN THE SEPTAL AND DISTAL 1MM OF THE TIP SNAPPED OFF. THE SEPARATED TIP WAS MARRIED TO END OF THE GUIDE WIRE AND CAUGHT ENOUGH TO GET BACK INTO A GUIDE CATHETER AND THE PHYSICIAN WAS ABLE TO TRAP IT OUT. IT WAS REPORTED THAT THE TIP OF AN ASAHI CORSAIR PRO XS MICROCATHETER SEPARATED DURING A PCI TO TREAT A CTO IN THE CORONARY ARTERY. THE CATHETER WAS CROSSING A SEPTAL CHANNEL WHEN IT GOT STUCK IN THE SEPTAL AND DISTAL 1MM OF THE TIP SNAPPED OFF. THE SEPARATED TIP WAS MARRIED TO END OF THE GUIDE WIRE, CAUGHT ENOUGH TO GET BACK INTO A GUIDE CATHETER, AND THE PHYSICIAN WAS ABLE TO TRAP IT OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10782576 ↗
• MalfunctionOct 14, 2020Entrapment of Device; Difficult to Remove

  PER DR. RILEY TEXT MESSAGE, "PRO XS 150 GOT STUCK IN A SEPTAL AND WOULDN'T COME OUT. LUCKILY TIP WAS MARRIED TO END OF THE WIRE AND CAUGHT ENOUGH TO GET BACK INTO GUIDE AND WE TRAPPED IT OUT DURING A LIVE CASE. ONLY (ABOUT) DISTAL 1MM TIP SNAPPED OFF, NOT THE WHOLE TIP."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10681277 ↗
• InjurySep 25, 2020Difficult to Remove; Material Twisted/Bent; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT AN ASAHI CONFIANZA PRO 8-20 GUIDE WIRE BECAME STUCK WITH AN ASAHI CORSAIR PRO XS MICROCATHETER DURING A PCI TO TREAT A MODERATELY CALCIFIED CTO IN THE RCA #2. THE TWO DEVICES WERE USED TOGETHER IN ATTEMPTS TO CROSS THE LESION WHEN THEY WERE NOTED TO BE STUCK WITH EACH OTHER IN THE LESION. BECAUSE BOTH DEVICES WERE DIFFICULT TO BE REMOVED, THE PROXIMAL SHAFT OF THE CORSAIR PRO XS WAS CUT TO DELIVER A GUIDING CATHETER OVER THE CORSAIR PRO XS. BOTH CONFIANZA PRO 8-20 AND CORSAIR PRO XS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE PCI WAS SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW BY STENT DEPLOYMENT. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10590620 ↗
• DeathSep 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2020, THIS WAS A PLANNED PERCUTANEOUS CORONARY INTERVENTION OF BOTH THE LAD ARTERY AND RAMUS INTERMEDIUS ARTERIES WITH IMPELLA SUPPORT DUE TO SEVERELY DEPRESSED BIVENTRICULAR FUNCTION. THE RAMUS ARTERY WAS FIRST TREATED BY STENT DEPLOYMENT. AFTER STENTING OF THE RAMUS WAS COMPLETED, DECISION WAS MADE TO PERFORM CTO-PCI OF THE PROXIMAL-MID LAD THAT APPEARED HEAVILY CALCIFIED. MULTIPLE WIRES ATTEMPTED TO CROSS THE CTO INCLUDING ASAHI WIRES: PROWATER, FIELDER XT, GLADIUS MONGO 14, CONFIANZA PRO 12, USING A WIRE ESCALATION AND DE-ESCALATION STRATEGY AND THE USE OF A 150 CM CORSAIR PRO XS MICROCATHETER. AFTER THE PROXIMAL CTO WAS CROSSED, THE DECISION WAS MADE TO ATTEMPT TO RE-ENTER THE TRUE LUMEN IN THE MID LAD WITH A STINGRAY BALLOON AND A STINGRAY GUIDE WIRE. A MIRACLEBROS 12 WAS PLACED INTO THE CORSAIR PRO XS TO EXCHANGE FOR A STINGRAY BALLOON. THE MIRACLEBROS 12 WAS IMMEDIATELY REMOVED AFTER THE STINGRAY BALLOON WAS IN PLACE, AND A STINGRAY WIRE WAS THEN ADVANCED THROUGH THE STINGRAY BALLOON FOR THE INITIAL ATTEMPT AT RE-ENTRY. UNSUCCESSFUL WITH THE STINGRAY GUIDEWIRE. THEN IT WAS ATTEMPTED WITH CONFIANZA PRO 12. UNSUCCESSFUL. ADVANCED THE STINGRAY BA

  Patient problems: Perforation of Vessels

  MAUDE report 10475599 ↗
• MalfunctionAug 19, 2020Break; Separation Failure

  WHILE TRYING TO PENETRATE THIS HEAVILY CALCIFIED LAD WITH AN ASTATO XS 20 GUIDE WIRE WITH THE SUPPORT OF THE CORSAIR PRO XS MICROCATHETER, THE TIP OF THE CORSAIR PRO XS BROKE OFF OF THE DISTAL SEGMENT OF THE MICROCATHETER AND BECAME AFFIXED TO THE DISTAL SEGMENT OF THE ASTATO XS 20 GUIDE WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10428685 ↗