ASAHI Gladius Mongo14 AP14R023SRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04547327123686), received between Feb 18, 2020 and May 22, 2025 — classified as 9 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2025Peeled/Delaminated; Material Split, Cut or Torn; Peeled/Delaminated; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN ASAHI GLADIUS MONGO 14 GUIDE WIRE WAS USED FOR STENT DEPLOYMENT TO A HEAVILY CALCIFIED AND 75-90% OCCLUDED LESION FROM THE OSTIUM TO THE DISTAL SEGMENT IN THE LEFT CIRCUMFLEX ARTERY (LCX). ATTEMPTS TO CROSS THE LESION FAILED DUE TO THE ECCENTRICALLY CALCIFIED LESION. THE POLYMER JACKET OF THE GUIDE WIRE WAS DAMAGED BY THE CALCIUM. THERE WERE NO HEALTH HAZARDS CAUSED TO THE PATIENT, AND NO ADDITIONAL TREATMENTS WERE PERFORMED. THE SUBJECT GLADIUS MONGO 14 GUIDE WIRE WAS REMOVED, AND AN UNSPECIFIED NEW GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22067441 ↗
• MalfunctionMay 14, 2025Unraveled Material; Unraveled Material

  ATTEMPTED TO CROSS A HEAVILY CALCIFIED CIRCUMFLEX. HAD DIFFICULTY CROSSING THE ECCENTRIC ORGANIZED CALCIUM. WIRE APPEARED TO HAVE THE POLYMER JACKET COMPROMISED DUE TO THE PRESENCE OF THE CALCIUM. NO REMEDIAL ACTION TAKEN. WIRE AND ALL PIECES WERE REMOVED FROM VESSEL AND NEW WIRE WAS SELECTED. PATIENT WAS NOT IN NEED OF REMEDIAL ACTION FROM THE DEVICE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020903 ↗
• InjuryDec 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT CORONARY ARTERY (RCA). WHEN ATTEMPTS WERE MADE TO CROSS THE IN-STENT RESTENOSIS WITH AN ASAHI GLADIUS MONGO 14 GUIDE WIRE, THE WIRE TIP WAS FRACTURED. THE WIRE FRAGMENT WAS REMOVED BY SNARING AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS INFORMED THAT THE PATIENT WAS FINE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20922247 ↗
• MalfunctionNov 27, 2024Break; Break

  TIP OF MONGO WIRE BROKE OFF WHILE TRYING TO CROSS RCA IN-STENT RESTENOSIS LESION. WIRE WAS ABLE TO BE SNARED OUT AND CASE COMPLETED. PATIENT WAS DOING FINE AND PROCEDURE WAS A SUCCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789982 ↗
• InjuryOct 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ASAHI GLADIUS MONGO 14 GUIDE WIRE WAS USED TO BE ANTEGRADELY ADVANCED TO A HEAVILY CALCIFIED CTO IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI). AS MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS, THE PHYSICIAN DECIDED TO CHANGE THE ACCESS ROUTE TO BY WAY OF THE SAPHENOUS VEIN GRAFT (SVG). AFTER SEVERAL ATTEMPTS TO PUSH THE GLADIUS MONGO 14 IN THE OCCLUDED SVG, THE TIP SEGMENT OF THE GUIDE WIRE WAS DETACHED IN 2 MINUTES AND LEFT IN THE OCCLUDED SVG. AS THE PHYSICIAN DECIDED TO MAKE NO ATTEMPTS TO RETRIEVE THE DETACHED TIP, CONSERVATIVE TREATMENT WAS CHOSEN AND THE PROCEDURE WAS TERMINATED. IT WAS INFORMED THAT HERE WERE NO HAZARDOUS PATIENT EFFECTS SUCH AS COMPLICATIONS AND THE PATIENT IS DOING FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17910388 ↗
• MalfunctionSep 22, 2023Fracture; Fracture

  DR. RATHORE ATTEMPTED THE MONGO 14 THROUGH A CORSAIR MULTIPLE TIMES INTO THE RCA. ONCE HE DETERMINED THAT WE WERE NOT GOING TO CROSS HE ENGAGED THE SVG. THERE WAS ZERO FLOW IN THE RCA GRAPH AND 100% OCCLUDED. PHYSICIAN ATTEMPTED TO PROBE MONGO IN TO THE SVG AND AFTER TWO MINUTES THE DISTAL TIP BROKE INTO THE SVG LESION.

  Patient problems: Foreign Body In Patient

  MAUDE report 17804594 ↗
• InjuryJun 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SPRING COIL OF AN ASAHI GRAND SLAM GUIDE WIRE HAD FRACTURED AND THE TIP OF AN ASAHI GLADIUS MONGO 14 GUIDE WIRE BROKE OFF DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A >20MM LONG, HEAVILY CALCIFIED, CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) INCLUDING THE OSTIUM. THE GRAND SLAM WAS ADVANCED INTO A NON-ASAHI TURNPIKE SPIRAL MICROCATHETER IN AN ATTEMPT TO BASE AT THE PROXIMAL CAP OF THE CTO. IT WAS BELIEVED THAT THE TIP OF GRAND SLAM GOT CAUGHT IN THE CALCIUM AND STRIPPED OFF THE SPRING COIL. THE SPRING COIL WAS LEFT IN THE RCA CTO. GLADIUS MONGO 14 WAS LATER USED TO KNUCKLE THROUGH THE PROXIMAL CAP THAT WAS ALREADY BASED. HOWEVER, GLADIUS MONGO 14 WOULD NOT KNUCKLE AND USED AS PENETRATION WIRE UNTIL WIRE WAS EMBEDDED INTO CALCIFIED LESION. NO ATTEMPTS WERE MADE TO RETRIEVE BOTH WIRE TIPS AS THEY WERE IN THE SUBINTIMAL SPACE AND IN THE HEAVILY CALCIFIED CTO SEGMENT THAT WAS UNSUCCESSFULLY ATTEMPTED. BOTH ANTEGRADE AND RETROGRADE APPROACHES WERE MADE; HOWEVER, THE PROCEDURE WAS UNSUCCESSFULLY COMPLETED. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME WITHOUT ADVERSE EFFECTS. GLADIUS MONGO 14 IS

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 17222564 ↗
• MalfunctionJun 26, 2023Material Fragmentation; Material Fragmentation

  MONGO WAS ADVANCED INTO THE PRO XS 150 THROUGH SEPTAL COLLATERAL. XS TIP WAS POSITIONED INTO THE SUBINTIMAL SPACE IN PROX RCA. PHYSICIAN HAD WIRE KNUCKLED, UPON REMOVAL OF KNUCKLE THE TIP OF THE MONGO WIRE BROKE OFF.

  Patient problems: Foreign Body In Patient

  MAUDE report 17205953 ↗
• InjuryApr 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THROUGH MEDWATCH REPORT (UF REPORT #: (B)(4)) THAT AN ASAHI GLADIUS MONGO 14 GUIDE WIRE WAS FRACTURED AND UNABLE TO BE RETRIEVED FROM THE SMALL BRANCH OF THE DISTAL OBTUSE MARGINAL (OM) CHRONIC TOTAL OCCLUSION (CTO) DURING CARDIAC CATHETERIZATION WITH IMPELLA CP PERCUTANEOUS LVAD INSERTION AND REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14030589 ↗
• MalfunctionApr 1, 2022Break; Fracture; Difficult to Remove; Obstruction of Flow

  DURING CARDIAC CATHETERIZATION, GUIDE WIRE WAS FRACTURED AND UNABLE TO BE RETRIEVED FROM THE SMALL BRANCH OF THE DISTAL OBTUSE MARGINAL (OM) CHRONIC TOTAL OCCLUSION (CTO). WHAT WAS THE ORIGINAL INTENDED PROCEDURE?: IMPELLA CP PERCUTANEOUS LVAD INSERTION AND REMOVAL. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY): DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

  Patient problems: Insufficient Information

  MAUDE report 13983750 ↗
• InjuryNov 7, 2021Peeled/Delaminated; Material Deformation; Peeled/Delaminated; Material Deformation

  IT WAS REPORTED THAT THE POLYMER JACKET OF AN ASAHI GLADIUS MONGO 14 GUIDE WIRE WAS PARTIALLY OFF DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT A HEAVILY CALCIFIED, CHRONIC TOTAL OCCLUSION (CTO) IN THE MID DIAGONAL BRANCH. WHEN IT WAS ATTEMPTED TO WIRE THE DIAGONAL BRANCH WITH SUPPORT FROM AN ASAHI CORSAIR PRO XS MICROCATHETER, DIFFICULTY WAS MET DUE TO CALCIFICATION AND LESION AND THE MICROCATHETER COULD NOT BE ADVANCED. THE GUIDE WIRE WAS THEN REMOVED FROM THE PATIENT BODY TO INSPECT AND IT WAS FOUND THAT THE DISTAL PORTION OF THE POLYMER JACKET WAS OFF THE GUIDE WIRE. A NEW GLADIUS MONGO GUIDE WIRE WAS USED AND IT TOOK A DIFFERENT PATCH WHICH WAS MORE LUMINAL. THE PCI WAS SUCCESSFUL COMPLETED. THE PATIENT WAS REPORTEDLY DOING WELL AFTER THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12757121 ↗
• MalfunctionOct 18, 2021Difficult to Advance; Separation Problem

  PHYSICIAN TRIED TO WIRE DIAGONAL WITH SUPPORT FROM CORSAIR PRO XS. HAD DIFFICULTY WIRING THRU CALCIUM AND DISEASE, TRIED TO ADVANCE CORSAIR PRO XS, BUT COULD NOT. BROUGHT MONGO OUT OF BODY TO INSPECT AND SAW THE DISTAL PORTIAN OF JACKET WAS OFF WIRE. HE THEN USED A NEW MONGO WHICH TOOK A DIFFERENT PATCH WHICH WAS MORE LUMINAL AND SUCCESSFUL COMPLETED CASE.

  Patient problems: Insufficient Information

  MAUDE report 12648282 ↗
• InjuryOct 23, 2020Peeled/Delaminated; Peeled/Delaminated

  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 10731307 ↗
• MalfunctionOct 22, 2020Break; Failure to Advance

  DR. (B)(6) 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.

  Patient problems: Insufficient Information

  MAUDE report 10721919 ↗
• InjuryJul 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF TWO ASAHI GLADIUS MONGO 14 GUIDE WIRE SEPARATED DURING A PCI TO TREAT A HEAVILY CALCIFIED CTO IN THE RCA. THE PHYSICIAN WAS TRYING TO GET THROUGH A VERY CALCIFIED LESION WITH THE MONGO WIRE. AS HE WAS TRYING TO ADVANCE THE WIRE THROUGH THE LESION, TIP BECAME LODGED IN THE CALCIUM. WHEN HE TRIED TO REMOVE BY PULLING ON THE WIRE, BUT IT DID NOT RELEASE FROM THE CALCIUM. HE PULLED HARDER AND THAT IS WHEN THE WIRE TIP SEPARATED. THAT WAS WHAT HAPPENED WITH BOTH WIRES. HE FINISHED HE CASE USING TWO MORE MONGOS WITH NO ISSUES. HE STENTED OVER THE WIRE TIPS THAT WERE IN THE SUB-INTIMAL SPACE AND THERE WAS NO ISSUE FOR THE PATIENT. THIS REPORT IS ABOUT THE SECOND GUIDE WIRE. THE FIRST GUIDE WIRE IS REPORTED UNDER MFR REPORT #: 3003775027-2020-00103.

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 10274128 ↗
• InjuryJul 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF TWO ASAHI GLADIUS MONGO 14 GUIDE WIRE SEPARATED DURING A PCI TO TREAT A HEAVILY CALCIFIED CTO IN THE RCA. THE PHYSICIAN WAS TRYING TO GET THROUGH A VERY CALCIFIED LESION WITH THE MONGO WIRE. AS HE WAS TRYING TO ADVANCE THE WIRE THROUGH THE LESION, TIP BECAME LODGED IN THE CALCIUM. WHEN HE TRIED TO REMOVE BY PULLING ON THE WIRE, BUT IT DID NOT RELEASE FROM THE CALCIUM. HE PULLED HARDER AND THAT IS WHEN THE WIRE TIP SEPARATED. THAT WAS WHAT HAPPENED WITH BOTH WIRES. HE FINISHED HE CASE USING TWO MORE MONGOS WITH NO ISSUES. HE STENTED OVER THE WIRE TIPS THAT WERE IN THE SUB-INTIMAL SPACE AND THERE WAS NO ISSUE FOR THE PATIENT. THIS REPORT IS ABOUT THE FIRST GUIDE WIRE. THE SECOND GUIDE WIRE IS REPORTED UNDER MFR REPORT #: 3003775027-2020-00104.

  Patient problems: Device Embedded In Tissue or Plaque; Vessel Or Plaque, Device Embedded In

  MAUDE report 10268763 ↗
• MalfunctionJul 1, 2020Entrapment of Device; Difficult to Remove; Detachment of Device or Device Component

  HE WAS TRYING TO GET THROUGH A VERY CALCIFIED LESION WITH THE MONGO WIRE. AS HE WAS TRYING TO ADVANCE THE WIRE THROUGH THE LESION, TIP BECAME LODGED IN THE CALCIUM. WHEN HE TRIED TO REMOVE BY PULLING ON THE WIRE, BUT IT DID NOT RELEASE FROM THE CALCIUM. HE PULLED HARDER AND THAT IS WHEN THE WIRE TIP SEPARATED. THAT IS WHAT HAPPENED WITH BOTH WIRES. HE WAS MORE FRUSTRATED ABOUT LOSING WIRE POSITION THEN WITH THE WIRE TIP SEPARATION. HE FINISHED HE CASE USING TWO MORE MONGOS WITH NO ISSUES. HE STENTED OVER THE WIRE TIPS THAT WERE IN THE SUB-INTIMAL SPACE AND THERE WAS NO ISSUE FOR THE PATIENT. HE ALSO USED MONGO AGAIN TODAY IN ANOTHER CTO WITH NO PROBLEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10222147 ↗
• MalfunctionJul 1, 2020Entrapment of Device; Failure to Advance; Detachment of Device or Device Component

  HE WAS TRYING TO GET THROUGH A VERY CALCIFIED LESION WITH THE MONGO WIRE. AS HE WAS TRYING TO ADVANCE THE WIRE THROUGH THE LESION, TIP BECAME LODGED IN THE CALCIUM. WHEN HE TRIED TO REMOVE BY PULLING ON THE WIRE, BUT IT DID NOT RELEASE FROM THE CALCIUM. HE PULLED HARDER AND THAT IS WHEN THE WIRE TIP SEPARATED. THAT IS WHAT HAPPENED WITH BOTH WIRES. HE WAS MORE FRUSTRATED ABOUT LOSING WIRE POSITION THEN WITH THE WIRE TIP SEPARATION. HE FINISHED HE CASE USING TWO MORE MONGOS WITH NO ISSUES. HE STENTED OVER THE WIRE TIPS THAT WERE IN THE SUB-INTIMAL SPACE AND THERE WAS NO ISSUE FOR THE PATIENT. HE ALSO USED MONGO AGAIN TODAY IN ANOTHER CTO WITH NO PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10221909 ↗
• MalfunctionFeb 19, 2020Break; Break

  IT WAS REPORTED THAT AN ASAHI GLADIUS MONGO 14 GUIDE WIRE WAS USED IN A PCI TO TREAT A SIGNIFICANTLY TORTUOUS, SIGNIFICANTLY CALCIFIED CTO IN THE MID LAD. THE PHYSICIAN WAS INITIATING A CTO PCI CROSS OF THE LESION. AS THE WIRE WAS ADVANCED THROUGH THE COMPLEX ANATOMY, THE PHYSICIAN FOUND THAT THE WIRE BECAME STUCK. HE FELT THAT IT WAS EITHER BEHIND A STENT STRUT OR WAS WEDGED BADLY INTO THE 100% CALCIFIC LESION. AS HE PULLED BACKWARD, THE WIRE CAME APART ON THE SPRING COIL AND ELONGATED. HOWEVER, HE WAS ABLE TO RETRIEVE THE ENTIRE WIRE AND START OVER WITH A NEW ONE. THE WIRE WAS RETRIEVED SUCCESSFULLY BACK INTO THE CONCOMITANT CORSAIR PRO MICROCATHETER AND REMOVED FROM THE BODY. THE WIRE WAS IMMEDIATELY THROWN AWAY AND A NEW ONE RE-INTRODUCED. THE PHYSICIAN WAS ABLE TO GET THROUGH THE LESION AND EVENTUALLY TREAT THE CTO WITH GREAT PATIENT OUTCOME. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS WIRE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9730211 ↗
• MalfunctionFeb 18, 2020Material Separation; Material Deformation; Mechanical Jam

  THE PHYSICIAN WAS INITIATING A CTO PCI CROSS OF A MID-LAD LESION THAT HAD SIGNIFICANT CALCIFICATION. HE IS VERY FOND OF THE MONGO WIRE AS IT IS THE BEST 3G WIRE HE HAS. AS HE ADVANCED THE WIRE THROUGH THE COMPLEX ANATOMY, HE FOUND THAT THE WIRE BECAME STUCK. HE FELT THAT IT WAS EITHER BEHIND A STENT STRUT OR WAS WEDGED BADLY INTO THE 100% CALCIFIC LESION. AS HE PULLED BACKWARD, THE WIRE CAME APART ON THE SPRING COIL AND ELONGATED. HOWEVER, HE WAS ABLE TO RETRIEVE THE ENTIRE WIRE AND START OVER WITH A NEW ONE. THE WIRE WAS RETRIEVED SUCCESSFULLY BACK INTO THE CORSAIR PRO AND REMOVED FROM THE BODY. THE WIRE WAS IMMEDIATELY THROWN AWAY AND A NEW ONE RE-INTRODUCED. WIRE WAS SUCCESSFULLY RETRIEVED BACK INTO THE CORSAIR PRO AND THEN BACK INTO THE GUIDE CATHETER. PHYSICIAN WAS ABLE TO GET THROUGH THE LESION AND TREAT THE CTO.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 9724123 ↗