ASAHI Gladius Mongo14Recalls & reported problems across all models

We found 3 models of ASAHI Gladius Mongo14 by Asahi Intecc CO., Ltd. in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Feb 18, 2020 and Jul 23, 2025 — classified as 14 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ASAHI Gladius Mongo14 problems

ASAHI Gladius Mongo14 models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ASAHI Gladius Mongo14 AP14R023S

  Wire, guide, catheter
  20 reports
• ASAHI Gladius Mongo14 AP14R023P

  Wire, guide, catheter
  7 reports
• ASAHI Gladius Mongo14 AP14R323S

  Wire, guide, catheter
  1 report

Recent ASAHI Gladius Mongo14 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT HEAVILY CALCIFIED DIFFUSE LESIONS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND CHRONIC TOTAL OCCLUSION (CTO) IN THE MID-DISTAL RCA. AN ASAHI GLADIUS MG14 GUIDE WIRE WAS ADVANCED TO CROSS THE LESION WITH THE SUPPORT OF A TELEFLEX TURNPIKE MICROCATHETER. THE GUIDE WIRE CROSSED THE DIFFUSE LESIONS IN THE PROXIMAL RCA, BUT WAS NOT SUCCESSFUL IN CROSSING PROXIMAL CAP OF CTO. THE TIP OF THE GLADIUS MG14 GUIDE WIRE BROKE OFF IN THE PROXIMAL CAP AND THE GUIDE WIRE WAS THEN WITHDRAWN. AS ATTEMPTS TO CROSS THE CTO WITH AN ASAHI FIELDER XT GUIDE WIRE AND AN ASAHI GAIA GUIDE WIRE WERE ALSO UNSUCCESSFULLY, THE SEPARATED WIRE WAS LEFT IN SITU. A SECOND GLADIUS MG14 GUIDE WIRE WAS USED TO CROSS THE CTO AND THE WIRE TIP WAS ALSO BROKE OFF, WHICH WAS RETRIEVED FROM THE PATIENT ANATOMY BY SNARING. DECISION WAS MADE TO ABORT CROSSING THE CTO AND AN ANGIOPLASTY WAS PERFORMED FOR THE DIFFUSE LESIONS IN THE PROXIMAL RCA. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS RECOVERED ACCORDING TO NORMAL PROTOCOL AND DISCHARGED AFTER THE PROCEDURE. THE FIRST GLADIUS M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573712 ↗
• InjuryJul 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT HEAVILY CALCIFIED DIFFUSE LESIONS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND CHRONIC TOTAL OCCLUSION (CTO) IN THE MID-DISTAL RCA. AN ASAHI GLADIUS MG14 GUIDE WIRE WAS ADVANCED TO CROSS THE LESION WITH THE SUPPORT OF A TELEFLEX TURNPIKE MICROCATHETER. THE GUIDE WIRE CROSSED THE DIFFUSE LESIONS IN THE PROXIMAL RCA BUT WAS NOT SUCCESSFUL IN CROSSING PROXIMAL CAP OF CTO. THE TIP OF THE GLADIUS MG14 GUIDE WIRE BROKE OFF IN THE PROXIMAL CAP AND THE GUIDE WIRE WAS THEN WITHDRAWN. AS ATTEMPTS TO CROSS THE CTO WITH AN ASAHI FIELDER XT GUIDE WIRE AND AN ASAHI GAIA GUIDE WIRE WERE ALSO UNSUCCESSFULLY, THE SEPARATED WIRE WAS LEFT IN SITU. A SECOND GLADIUS MG14 GUIDE WIRE WAS USED TO CROSS THE CTO AND THE WIRE TIP WAS ALSO BROKE OFF, WHICH WAS RETRIEVED FROM THE PATIENT ANATOMY BY SNARING. DECISION WAS MADE TO ABORT CROSSING THE CTO AND AN ANGIOPLASTY WAS PERFORMED FOR THE DIFFUSE LESIONS IN THE PROXIMAL RCA. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS RECOVERED ACCORDING TO NORMAL PROTOCOL AND DISCHARGED AFTER THE PROCEDURE. THE FIRST GLADIUS MG

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22573711 ↗
• InjuryJul 23, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED TO TREAT A VERY DIFFICULT AND HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE PROXIMAL 2ND OBTUSE MARGINAL BRANCH (OM2). WHEN AN ASAHI GLADIUS MONGO 14 GUIDE WIRE WAS ADVANCED TO CROSS THE LESION WITH THE SUPPORT OF A TELEFLEX TURNPIKE MICROCATHETER, THE WIRE TIP BROKE OFF IN THE SUBINTIMAL SPACE. AFTER THE GLADIUS MONGO 14 GUIDE WIRE WAS WITHDRAWN, A ROTAWIRE WAS INSERTED AND ROTATIONAL ATHERECTOMY WAS PERFORMED. THE SEPARATED WIRE FRAGMENT REMAINED IN THE SUBINTIMAL SPACE. THE PHYSICIAN DECIDED TO LEAVE IT IN SITU AND THERE WAS NO INJURY TO THE PATIENT. IT WAS INFORMED THAT THE PATIENT WAS FINE AND RECOVERED ACCORDING TO STANDARD PROTOCOL AFTER THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22573709 ↗
• MalfunctionJul 18, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IN PREVIOUS REPORT #56898, A SECOND GLADIUS MONGO 14 WAS USED TO ATTEMPT TO CROSS THE CTO. THIS WIRE EXPERIENCED A BROKEN TIP, WAS RETRIEVED AND REMOVED FROM THE PATIENT. THIS IS ADDITIONAL INFORMATION RECEIVED TODAY AND UNKNOWN IN PREVIOUS REPORT. PATIENT STABLE AND RECOVERED ACCORDING TO NORMAL PROTOCOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22542399 ↗
• MalfunctionJul 16, 2025Break; Material Fragmentation; Break; Material Fragmentation

  GLADIUS MONGO 14 WITH A TURNPIKE MICROCATHETER TRAVERSED THRU DIFFUSE PROXIMAL RCA DISEASE BUT WAS NOT SUCCESSFUL IN CROSSING PROXIMAL CAP OF CTO. GLADIUS MONGO TIP BROKE OFF IN THE PROXIMAL CAP AND WIRE WAS REMOVED. ATTEMPTS TO CROSS THE CTO WERE MADE WITH A FIELDER XT AND GAIA BUT WERE UNSUCCESSFUL. DECISION WAS MADE TO ABORT CROSSING THE CTO AND LEAVE TIP IN VESSEL. AN ANGIOPLASTY WAS PERFORMED IN THE PROXIMAL DIFFUSE DISEASE. A SECOND GLADIUS MONGO 14 WAS USED AND ALSO HAD A TIP BREAK. (I WILL CREATE A SEPARATE REPORT FOR THIS WIRE).

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

  MAUDE report 22521881 ↗
• MalfunctionJul 16, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  UPON TRAVERSING THROUGH THE CIRCUMFLEX ARTERY, ATTEMPT WAS MADE TO ACCESS AND CROSS A PROXIMAL OM2 CTO. THE GLADIUS MONGO 14 WAS SUPPORTED WITH A TURNPIKE MICROCATHETER. THESE VESSELS WERE REPORTED TO BE HEAVILY CALCIFIED. THE DISTAL TIP OF THE GLADIUS MONGO BROKE OFF IN THE INTIMAL SPACE OF THE OM2. THE GLADIUS MONGO WAS REMOVED AND THE DECISION WAS MADE TO ATTEMPT A ROTOBLATOR INTERVENTION. A ROTO WIRE WAS INSERTED AND AN ATHERECTOMY OF THE PROXIMAL DISEASE WAS PERFORMED. THE TIP OF THE GLADIUS MONGO WAS LEFT IN THE SUBINTIMAL SPACE WITH NO INJURY TO PATIENT. RISK MANAGEMENT WAS ALERTED TO THE EVENT AND THEY COMPLETED A MED WATCH REPORT.

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

  MAUDE report 22520399 ↗
• 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 ↗
• InjuryFeb 25, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ASAHI GLADIUS MONGO14 GUIDE WIRE WAS USED WITH AN ASAHI CORSAIR PRO XS MICROCATHETER TO APPROACH A MODERATELY CALCIFIED AND MODERATELY TORTUOUS CHRONIC TOTAL OCCLUSION (CTO) CAUSED BY IN-STENT RESTENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA) DURING PERCUTANEOUS CORONARY INTERVENTION (PCI). THE GLADIUS MONGO14 GUIDE WIRE MET RESISTANCE AT THE PROXIMAL CAP OF THE CTO, BUT WAS ADVANCED IN AN ATTEMPT TO CROSS THE LESION. WHEN WITHDRAWAL FROM THE CORSAIR PRO XS MICROCATHETER WAS ATTEMPTED, THE DISTAL SEGMENT OF THE GLADIUS MONGO14 GUIDE WIRE WAS FRACTURED. IT WAS INFORMED THAT THE DETACHED FRAGMENT WAS STENTED TO THE VESSEL WALL, AND THE PATIENT WAS DISCHARGED IN A GOOD CONDITION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21465766 ↗
• 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 ↗

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