ASAHI Gladius Mongo14 AP14R023PRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04547327123693), received between May 1, 2023 and Jul 23, 2025 — classified as 4 injuries, 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, 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 THE TIP OF THE GLADIUS MG14 GUIDE WIRE BROKE OFF IN THE PROXIMAL CAP AND THE GUIDE WIRE WAS THEN WITHDRAWN.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 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI GLADIUS MG14 GUIDE WIRE HAD DETACHED DURING A PLAIN OLD BALLOON ANGIOPLASTY (POBA) TO TREAT A NON-CALCIFIED OCCLUSION IN THE PROXIMAL RIGHT CORONARY ARTERY. DURING THE PROCEDURE, LOSS OF A 1 CM PIECE OF THE TIP OF THE GUIDEWIRE IN THE RIGHT CORONARY PROXIMAL WAS NOTED. THE GUIDE WIRE WAS USED SUBINTIMALLY BY KNUCKLE WIRE TECHNIQUE WITHOUT ANY PARTICULAR MISHANDLING BY THE OPERATOR. THE PIECE OF THE GUIDE WIRE WAS NOT RETRIEVED AND LEFT IN THE PATIENT'S CORONARY ARTERY. ANOTHER PCI IS PLANNED TO BE PERFORMED IN A MONTH TO STENT THE REMAINING PIECE OF THE GUIDE WIRE (NOT YET CONDUCTED AS OF ON (B)(6) 2023). THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PATIENT OUTCOME AFTER THE PROCEDURE WAS FINE AND THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Foreign Body In Patient

  MAUDE report 16842582 ↗