ASAHI Corsair Pro XS CSR135-21SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04547327123662), received between Oct 7, 2020 and May 31, 2022 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT HAD A NEAR COMPLETE CHRONIC TOTAL OCCLUSION (CTO) OF THE RIGHT CORONARY ARTERY (RCA) EXTENDING FROM MID-PROXIMAL RCA TO THE BIFURCATION OF THE POSTER DESCENDING BRANCH (PDA) AND POSTEROLATERAL BRANCH (PL). PRIOR STENT WAS PLACED AT THE VERY DISTAL SEGMENT OF THE RCA TO THE BIFURCATION. SUBINTIMAL TRACKING WITH RE-ENTRY WAS PLANNED IN STENT STRUT SEGMENT. IT WAS DIFFICULT TO ADVANCE AN UNSPECIFIED MICROCATHETER OVER AN ASAHI GUIDE WIRE. PHYSICIAN THEN SWITCHED OUT TO NON-ASAHI GUIDE WIRE. THE GUIDE WIRE WAS ABLE TO ADVANCE. THE CORSAIR PRO XS MICROCATHETER WAS ADVANCED FOLLOWING THE GUIDE WIRE, BASKET WEAVING IN AND OUT OF THE STENT STRUTS. THERE WAS A POINT WHERE THE CORSAIR PRO XS WAS TORQUED AND IT POPPED THROUGH, SIMILAR TO A MICROCATHER CROSSING A CALCIFIED CAP. THIS WAS MORE THAN LIKELY WHEN THE TIP RUBBED AGAINST THE EXISTING STENT STRUT. AFTER THE INITIAL PROCESS, THE GUIDE WIRE MARRIED TO THE CORSAIR PRO XS. ADVANCEMENT INTO THE PL OR PDA WAS TERMINATED AND BOTH PIECES OF EQUIPMENT WERE REMOVED. PHYSICIAN NOTED THE TIP OF THE CORSAIR PRO XS LOOKED SHREDDED. IT WAS NOTED THAT A PIECE OF THE TIP HAD BEEN LEFT IN THE SUBINTIMAL SPACE. NO ATTEMP

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14545912 ↗
• InjuryMay 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CORSAIR PRO XS MICROCATHETER HAD DISLODGED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A SEVERELY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE MID RIGHT CORONARY ARTERY (RCA). AFTER WIRING THE LESION, MULTIPLE NON-ASAHI MICROCATHETER AND 1.0 OR 1.5 BALLOONS WERE USED BUT THOSE WERE UNABLE TO CROSS. THE CORSAIR PRO XS WAS THEN ADVANCED BY TORQUING INTO THE LESION; HOWEVER, THE TIP BROKE OFF DUE TO THE VERY COMPLICATED CTO. BALLOON-ASSISTED SUBINTIMAL ENTRY (BASE) WAS PERFORMED PROXIMAL TO THE LESION TO COMPLETE THE CASE. THE SEPARATED TIP WAS DEEPLY BURIED IN THE LESION AND THEREFORE LEFT IN SITU. AS A STENT DEPLOY AT THE LESION COVERED THE SEPARATED TIP, THERE WERE NO CIRCULATION PROBLEMS. THERE WAS NO ADVERSE EFFECT ON THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14519721 ↗
• MalfunctionMay 19, 2022Material Split, Cut or Torn

  PT HAD A NEAR COMPLETE CTO OF THE RCA EXTENDING FROM MID-PROX RCA TO THE BIFURCATION OF THE PDA/PL. PRIOR STENT PLACED AT THE VERY DISTAL SEGMENT OF THE RCA TO THE BIFURCATION. POSSIBLE SUBINTIMAL TRACKING WITH RE-ENTRY PRIOR TO DISTAL STENT. PHYSICIAN BELIEF THAT SUBINTIMAL RE-ENTRY IN STENT STRUT SEGMENT. DIFFICULTY ADVANCING MC OVER MONGO. PHYSICAIN SWITCHED OUT TO PILOT 200, WIRE WAS ABLE TO ADVANCE. WIRE MARRIED TO THE MC AT THIS TIME. XS AND PILOT 200 REMOVED, PHYSICIAN NOTED THE TIP LOOK SHREDDED. PER DR. KOURANY, "A SLIVER OF THE TIP WAS LEFT IN THE SUBINTIMAL SPACE. I BELIEVE THE TIP WAS DEFORMED PASSING THROUGH THE EXISTING STENT STRUTS."

  Patient problems: Foreign Body In Patient

  MAUDE report 14438434 ↗
• MalfunctionMay 12, 2022Entrapment of Device

  TIP WAS DISLODGED IN LESION.

  Patient problems: Foreign Body In Patient

  MAUDE report 14367144 ↗
• MalfunctionFeb 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI CORSAIR PRO XS MICROCATHETER DETACHED DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A HEAVILY CALCIFIED 90-95% STENOSIS IN THE MID LEFT CIRCUMFLEX ARTERY (LCX). THE PHYSICIAN USED A NON-ASAHI RUNTHROUGH WIRE TO CROSS THE MID LCX HEAVILY CALCIFIED LESION. FIRST HE USED A NON-ASAHI TURNPIKE SPIRAL MICROCATHETER BUT IT WAS UNABLE TO ADVANCE ACROSS LESION. HE THEN TRIED CORSAIR PRO XS. HE WAS UNABLE TO ADVANCE ACROSS THE LESION. WHEN HE TRIED TO REMOVE THE CORSAIR PRO XS, HE NOTICED THE MICROCATHETER WOULD NOT COME OFF WIRE. HE PULLED THE MICROCATHETER AND WIRE OUT OF THE GUIDE. HE NOTICED THE TIP WAS SEPARATED FROM THE SHAFT AND WAS STUCK ON THE WIRE. HE USED ANOTHER RUNTHROUGH WIRE TO CROSS THE LESION. THEN HE USED A NON-ASAHI MAMBA FLEX MICROCATHETER AND TRIED TO CROSS THE LESION BUT IT WOULD NOT CROSS THE LESION. THE PATIENT WAS FINE, NO ADVERSE OUTCOMES ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391022 ↗
• MalfunctionFeb 19, 2021Material Separation; Failure to Advance; Mechanical Jam

  PER SCRUB TECH-DR. BISEN USED A TERUMO RUNTHROUGH WIRE TO CROSS MID CX HEAVILY CALCIFIED LESION. FIRST HE USED A TURNPIKE SPIRAL MICROCATHETER BUT IT WAS UNABLE TO ADVANCE ACROSS LESION. HE THEN TRIED CORSAIR PRO XS. HE WAS UNABLE TO ADVANCE ACROSS THE LESION. WHEN HE TRIED TO REMOVE THE CORSAIR PRO XS, HE NOTICED THE MICROCATHETER WOULD NOT COME OFF WIRE. HE PULLED MC AND WIRE OUT OF THE GUIDE. HE NOTICED THE TIP WAS SEPARATED FROM THE SHAFT AND WAS STUCK ON THE WIRE. HE USED ANOTHER RUNTHROUGH WIRE TO CROSS THE LESION. THEN HE USED A MAMBA FLEX MICROCATHETER AND TRIED TO CROSS THE LESION BUT IT WOULDN'T CROSS THE LESION. HE REMOVED THE MAMBA AND WIRE BECAUSE HE NOTICED THAT THE TIP HAD ALSO SEPARATED FROM THE MAMBA MC. PATIENT WAS FINE, NO ADVERSE OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11350032 ↗
• InjuryFeb 9, 2021Material Fragmentation; Difficult to Remove; Material Twisted/Bent; Material Fragmentation; Difficult to Remove; Material Twisted/Bent

  IT WAS REPORTED THAT AN ASAHI CORSAIR PRO XS MICROCATHETER BECAME STUCK ON A CONCOMITANT GUIDE WIRE DURING A RETROGRADE PCI TO TREAT A CTO IN THE DISTAL RCA. THE MICROCATHETER WAS DELIVERED TO THE RCA VIA THE SVG WHEN THE CORSAIR PRO XS GOT STUCK IN A PREVIOUSLY PLACED STENT IN THE SVG. WHEN TRYING TO REMOVE THE MICROCATHETER, IT BECAME TRAPPED ON THE WIRE. DURING ATTEMPTS TO REMOVE THE MICROCATHETER, THE HUB PULLED OFF THE MICROCATHETER SHAFT. SUBSEQUENTLY THE MICROCATHETER AND THE OLD STENTS HAD TO BE SNARED. THE PCI WAS SUCCESSFULLY COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PHYSICIAN COMMENTED THAT HE DID NOT THINK THE MICROCATHETER GETTING STUCK WAS A FAILURE OF THE MICROCATHETER. THE WIRE MUST HAVE GOTTEN BEHIND THE STENT AND THAT WAS WHY THE MICROCATHETER GOT TRAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11299353 ↗
• MalfunctionJan 27, 2021Entrapment of Device; Physical Resistance/Sticking

  WHILE USING THE SVG TO RCA AS A RETROGRADE APPROACH, THE CORSAIR PRO XS GOT STUCK IN A PREVIOUSLY PLACED STENT IN THE SVG. WHEN TRYING TO REMOVE THE MC, THE CATHETER BECAME TRAPPED ON THE WIRE. AS DR. NEUPANE TRIED TO PULL THE MC BACK, THE HUB PULLED OFF THE MC AND HE SUBSEQUENTLY HAD TO SNARE THE MC AND OLD STENTS OUT.

  Patient problems: Insufficient Information

  MAUDE report 11237972 ↗
• MalfunctionOct 23, 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 BROKE OFF DURING A PCI TO TREAT A CTO IN THE MID LCX. AN ASAHI GLADIUS MONGO GUIDE WIRE WAS ABLE TO CROSS THE CTO. A NON-ASAHI MAMBA FLEX MICROCATHETER FOLLOWED BUT FAILED TO CROSS THE LESION. THE CORSAIR PRO XS WAS THEN ADVANCED FURTHER, BUT NOT TOTALLY ACROSS THE CTO CAP. CLOCKWISE AND COUNTER CLOCKWISE ROTATIONS WERE APPLIED, BUT THE CORSAIR PRO XS WAS NOT ADVANCING ANY FURTHER. UPON REMOVAL, IT WAS NOTICED THAT THE TIP OF THE CORSAIR PRO XS BROKEN OFF, AND WAS STUCK ON THE GUIDE WIRE. THE GLADIUS MONGO WITH THE SEPARATED TIP WAS ALSO REMOVED SO THAT NOTHING LEFT BEHIND. ATTEMPTS WERE MADE TO REWIRE THE VESSEL, BUT WAS UNABLE TO ADVANCE ANY MICROCATHETER, OR BALLOON THROUGH THE CTO CAP. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10731304 ↗
• MalfunctionOct 7, 2020Break; Difficult to Insert

  (B)(6) IS WORKING ON CX CTO. WAS ABLE TO GET GLADIUS MONGO GW ACROSS CTO. HE WAS USING A MAMBA FLEX MC FIRST. THAT WAS UNABLE TO CROSS CTO. HE ASKED FOR CORSAIR PRO XS. WAS ABLE TO ADVANCE FURTHER, BUT NOT TOTALLY ACROSS CTO CAP. HE DID CLOCKWISE AND COUNTER-CLOCKWISE ROTATIONS. THE CP XS WAS NOT ADVANCING AY FURTHER. HE THEN WENT TO REMOVE THE CP XS. HE NOTICED THAT THE TIP OF CP XS WAS BROKEN OFF, AND WAS STUCK ON WIRE. ON ANGIO IT DIDN'T LOOK LIKE THERE WAS CALCIUM BUT CTO CAP WAS EXTREMELY HARD. ONCE HE REMOVED THE BODY OF THE CP XS, HE REMOVED THE GLADIUS MONGO GUIDEWIRE, WHICH HAD THE TIP ON THE MC FUSED TO THE WIRE. SO ENTIRE TIP WAS REMOVED FROM PATIENT, NOTHING LEFT BEHIND. HE REWIRED THE VESSEL, BUT WAS UNABLE TO ADVANCE ANY MICROCATHETER, OR BALLOON THROUGH THE CTO CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10646533 ↗