ASAHI Gladius Mongo14 ES AP14R324PRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04547327123754), received between Mar 15, 2021 and Oct 17, 2024 — classified as 6 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PERIPHERAL PERCUTANEOUS INTERVENTION (PPI) WAS PERFORMED FOR A HEAVILY CALCIFIED, MODERATELY TORTUOUS, AND 90-99% OCCLUDED LESION IN THE ANTERIOR TIBIAL ARTERY (ATA). WHEN AN ATTEMPT WAS MADE WITH AN ASAHI GLADIUS MONGO 14 ES GUIDE WIRE, INSERTED IN AN ASAHI CROSSLEAD PERIPHERAL SUPPORT CATHETER, TO PERFORM PEDAL LOOP REVASCULARIZATION. DURING PROCEDURE, THE SUBJECT GLADIUS MONGO 14 ES GUIDE WIRE WAS CAUGHT IN THE DISTAL TIBIAL ARTERY (TA). AFTER SEVERAL WITHDRAWAL ATTEMPTS WITH DIFFICULTY, THE GUIDE WIRE WAS REMOVED BUT FOUND ITS DISTAL SEGMENT DETACHED. AN UNSPECIFIED MICRO SNARE WAS USED AND THE WIRE FRAGMENT WAS SUCCESSFULLY RETRIEVED. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS AND THE PROCEDURE WAS TERMINATED. THE PATIENT WAS REPORTEDLY DISCHARGED AFTER HEMOSTASIS WAS ACHIEVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20478017 ↗
• MalfunctionOct 3, 2024Break; Break

  WHILE WORKING ON VERY CALCIFIC AND DIFFUSELY DISEASED ANTERIOR TIBIAL ARTERY, THE MONGO ES .014 WIRE BECAME TRAPPED IN THE DISTAL AT BY THE PEDAL LOOP WHILE IN THE .014 170CM CROSSWALK. IT WAS NOTED THAT WHEN THE WIRE WAS FINALLY ABLE TO BE REMOVED, THE DISTAL TIP OF THE WIRE WAS DISCONNECTED FROM THE REST OF THE WIRE. A MICRO SNARE WAS USED TO SUCCESSFULLY REMOVE THE BROKEN PIECE OF THE WIRE. NO ISSUES WERE NOTED, AND CASE WAS TERMINATED. PATIENT WAS RECOVERED IN THE RECOVERY AREA UNTIL HEMOSTASIS OF FEMORAL SITE WAS SEALED, THEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20364338 ↗
• InjuryApr 7, 2021Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO SEPARATE PROCEDURES WERE PERFORMED TO TREAT LOW TO MODERATE CALCIUM AND SUBTOTALED LESIONS IN THE SUPERFICIAL FEMORAL ARTERY, ACCESSING THROUGH PEDAL OR COMMON FEMORAL ARTERY. AN ASAHI GLADIUS MONGO ES GUIDE WIRE WAS USED IN EACH PROCEDURE WHEN IT BECAME APART AT THE DISTAL END OF THE WIRE. THE PHYSICIAN MANAGED TO REMOVE BOTH WIRES INTACT, THAT WERE HELD TOGETHER SOMEHOW, AND FINISHED CASE INTERVENTION WITHOUT A PROBLEM. THE PATIENT IS OK AND BOTH CASES COMPLETED SUCCESSFULLY. NO OTHER INFORMATION GIVEN AND PRODUCT NOT SAVED. TWO GUIDE WIRES ARE REPORTED UNDER 3003775027-2021-00069 AND 3003775027-2021-00070 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11625731 ↗
• InjuryApr 5, 2021Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT TWO SEPARATE PROCEDURES WERE PERFORMED TO TREAT LOW TO MODERATE CALCIUM AND SUBTOTALED LESIONS IN THE SUPERFICIAL FEMORAL ARTERY, ACCESSING THROUGH PEDAL OR COMMON FEMORAL ARTERY. AN ASAHI GLADIUS MONGO ES GUIDE WIRE WAS USED IN EACH PROCEDURE WHEN IT BECAME APART AT THE DISTAL END OF THE WIRE. THE PHYSICIAN MANAGED TO REMOVE BOTH WIRES INTACT, THAT WERE HELD TOGETHER SOMEHOW, AND FINISHED CASE INTERVENTION WITHOUT A PROBLEM. THE PATIENT IS OK AND BOTH CASES COMPLETED SUCCESSFULLY. NO OTHER INFORMATION GIVEN AND PRODUCT NOT SAVED. TWO GUIDE WIRES ARE REPORTED UNDER 3003775027-2021-00070 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11616931 ↗
• InjuryMar 28, 2021Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS 75-90% STENOSIS IN THE HEAVILY TORTUOUS DISTAL POSTERIOR TIBIAL ARTERY (PT). TWO ASAHI GLADIUS MONGO ES GUIDE WIRES FAILED TO CROSS A TIGHT ANGLE BEFORE THE TARGET LESION. WHEN HE REMOVED THE FIRST WIRE TO USE A DIFFERENT WIRE, HE NOTICED THAT THE TIP HAD FRACTURED AND THE POLYMER JACKET HAD SEPARATED AND THE INNER CORE OF THE WIRE WAS EXPOSED. THE SECOND WIRE WAS PULLED FROM THE SAME BOX WITH THE SAME LOT NUMBER; HOWEVER, IT WAS UNABLE TO NAVIGATE AT THE SAME POINT OF THE ANGLED, DISTAL PT. WHEN THE SECOND WIRE WAS REMOVED, IT WAS FOUND THE SAME FRACTURE OCCURRED AS WITH THE FIRST WIRE. A NON-ASAHI V-18 CONTROLWIRE WAS REPLACED AND SUCCESSFULLY NAVIGATED THE TORTUOSITY AND SUCCESSFULLY CROSSED THE LESION. THE ARTERY WAS LASERED AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO SUCCESSFULLY OPEN THE ARTERY. THE FIRST AND SECOND WIRES ARE REPORTED UNDER 3003775027-2021-00062 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580494 ↗
• InjuryMar 28, 2021Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED THAT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS 75-90% STENOSIS IN THE HEAVILY TORTUOUS DISTAL POSTERIOR TIBIAL ARTERY (PT). TWO ASAHI GLADIUS MONGO ES GUIDE WIRES FAILED TO CROSS A TIGHT ANGLE BEFORE THE TARGET LESION. WHEN HE REMOVED THE FIRST WIRE TO USE A DIFFERENT WIRE, HE NOTICED THAT THE TIP HAD FRACTURED AND THE POLYMER JACKET HAD SEPARATED AND THE INNER CORE OF THE WIRE WAS EXPOSED. THE SECOND WIRE WAS PULLED FROM THE SAME BOX WITH THE SAME LOT NUMBER; HOWEVER, IT WAS UNABLE TO NAVIGATE AT THE SAME POINT OF THE ANGLED, DISTAL PT. WHEN THE SECOND WIRE WAS REMOVED, IT WAS FOUND THE SAME FRACTURE OCCURRED AS WITH THE FIRST WIRE. A NON-ASAHI V-18 CONTROLWIRE WAS REPLACED AND SUCCESSFULLY NAVIGATED THE TORTUOSITY AND SUCCESSFULLY CROSSED THE LESION. THE ARTERY WAS LASERED AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED TO SUCCESSFULLY OPEN THE ARTERY. THE FIRST AND SECOND WIRES ARE REPORTED UNDER 3003775027-2021-00063 RESPECTIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580492 ↗
• MalfunctionMar 26, 2021Fracture; Material Separation

  AFTER THE FRACTURE AND REMOVAL OF THE 1ST MONGO ES PRE-SHAPED WIRE DR. (B)(6) ASKED FOR A 2ND MONGO ES PRE-SHAPED WIRE (WHICH CAME OUT OF THE SAME BOX WITH THE SAME LOT#) AND HE INSERTED IT DOWN TO THE DISTAL PT WHERE HE AGAIN WAS UNABLE TO NAVIGATE THE TORTUOSITY AND CROSS THE LESION. WHEN HE REMOVED THE WIRE HE AGAIN NOTIFIED ME THAT THE 2ND MONGO ES PRE-SHAPE WIRE HAD FRACTURED AND SEPARATED FROM THE POLYMER JACKET LIKE THE 1ST ONE. .

  Patient problems: Insufficient Information

  MAUDE report 11576321 ↗
• MalfunctionMar 26, 2021Fracture; Material Separation

  THIS WIRE WAS USED TO NAVIGATE A TORTUOUS DISTAL PT. DR. (B)(6) WAS ATTEMPTING TO NAVIGATE THE WIRE AROUND A TIGHT ANGLE AND WAS UNSUCCESSFUL. WHEN HE REMOVED THE WIRE TO USE A DIFFERENT WIRE HE NOTICED THAT THE TIP HAD FRACTURED AND THE POLYMER JACKET HAD SEPARATED AND THE INNER CORE OF THE WIRE WAS EXPOSED. UNFORTUNATELY ANOTHER MONGO ES PRE-SHAPED WIRE WAS PULLED FROM THE SAME BOX WITH THE SAME LOT# AND THAT WIRE FRACTURED IN THE SAME WAY AT THE SAME POINT OF THE ANGLED, DISTAL PT.

  Patient problems: Insufficient Information

  MAUDE report 11576149 ↗
• MalfunctionMar 25, 2021Detachment of Device or Device Component

  DR. (B)(6) HAD TWO MORE GLADIUS MONGO ES PRE-SHAPE WIRES DETATCH AND COME APART AT THE DISTAL END OF THE WIRE. TWO SEPARATE CASES. BOTH SFA INTERVENTIONS. LOW TO MODERATE CALCIUM AND SUBTOTALED LESIONS. ACCESS WAS BOTH PEDAL AND CFA RESPECTIVELY. THIS IS THE THIRD PRE-SHAPE MONGO ES THIS USER HAS HAD A BREAKAGE WITHIN A TWO WEEK TIMEFRAME ALL THE SAME LOT#. PHYSICIAN MANAGED TO REMOVE BOTH WIRES INTACT, HELD TOGETHER SOMEHOW AND FINISHED CASE INTERVENTION WITHOUT A PROBLEM. PATIENT IS OK AND CASE COMPLETED SUCCESSFULLY. NO OTHER INFORMATION GIVEN AND PRODUCT NOT SAVED.

  Patient problems: Insufficient Information

  MAUDE report 11572280 ↗
• MalfunctionMar 24, 2021Break; Detachment of Device or Device Component

  DR. (B)(6) HAD TWO MORE GLADIUS MONGO ES PRE-SHAPE WIRES DETACHED AND COME APART AT THE DISTAL END OF THE WIRE. TWO SEPARATE CASES. BOTH SFA INTERVENTIONS. LOW TO MODERATE CALCIUM AND SUBTOTALED LESIONS. ACCESS WAS BOTH PEDAL AND CFA RESPECTIVELY. THIS IS THE THIRD PRE-SHAPE MONGO ES THIS USER HAS HAD A BREAKAGE WITHIN A TWO WEEK TIMEFRAME ALL THE SAME LOT#. PHYSICIAN MANAGED TO REMOVE BOTH WIRES INTACT, HELD TOGETHER SOMEHOW AND FINISHED CASE INTERVENTION WITHOUT A PROBLEM. PATIENT IS OK AND CASE COMPLETED SUCCESSFULLY. NO OTHER INFORMATION GIVEN AND PRODUCT NOT SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11564165 ↗
• InjuryMar 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI GLADIUS MONGO ES GUIDE WIRE SEPARATED AND REMAINED IN THE PATIENT DURING INTERVENTION TO TREAT A HEAVILY CALCIFIED, IN-STENT RESTENOSED CHRONIC TOTAL OCCLUSION (ISR-CTO) IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). ACCESS WAS THE RIGHT POSTERIOR TIBIAL ARTERY BY MICROPUNCTURE AND UPSIZED TO A 6 FRENCH SHEATH. THE PHYSICIAN USED A NON-ASAHI 0.035 INCH TRAILBLAZER CATHETER AND GLADIUS MONGO ES 014 GUIDEWIRE TO ATTEMPT TO CROSS THE LESION. THE GUIDE WIRE AND CATHETER MADE ITS WAY DISTAL TOWARDS THE OSTIUM OF THE SFA WHERE PROXIMAL CTO CAP WAS. AFTER SPINNING THE WIRE AND PUSHING WITHIN THE LESION, THE RADIOPAQUE SEGMENT AT THE TIP OF THE WIRE BROKE OFF. PHYSICIAN NOTED HE WAS SPINNING AGGRESSIVELY BUT HAS USED THAT TECHNIQUE FOR YEARS. THE PHYSICIAN CONTINUED TO WORK ON THE PATIENT WITH A 0.035 INCH SYSTEM THAT EVENTUALLY CROSSED AND SUCCESSFULLY TREATED THE PATIENT. THE WIRE FRAGMENT WAS LEFT IN THE PATIENT, MOST LIKELY TACKED UP WITH STENT. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11536988 ↗
• MalfunctionMar 15, 2021Break; Difficult to Remove

  PATIENT WAS SCHEDULED FOR RIGHT LOWER EXTREMITY ANGIO WITH INTERVENTION OF AN OCCLUDED SFA WITH ISR. ACCESS WAS THE RIGHT POSTERIOR TIBIAL ARTERY BY MICROPUNCTURE AND UPSIZED TO A 6 FRENCH SHEATH. PHYSICIAN USED AN 035 TRAILBLAZER CATHETER AND GLADIUS MONGO ES 014 GUIDEWIRE TO ATTEMPT TO CROSS CTO OF ISR OF RIGHT SFA. THE MONGO ES AND CATHETER MADE ITS WAY DISTAL TOWARDS THE OSTIUM OF THE SFA WHERE PROXIMAL CTO CAP WAS. AFTER SPINING THE WIRE AND PUSHING WITHIN THE LESION, THE RADIOPAQUE SEGMENT AND TIP OF THE WIRE BROKE OFF. PHYSICIAN NOTED HE WAS SPINING AGGRESSIVELY BUT HAS USED THAT TECHNIQUE FOR YEARS. THERE WAS NO PATIENT HARM AND WE CONTINUED TO WORK ON THE PATIENT WITH A 035 SYSTEM THAT EVENTUALLY CROSSED AND WE SUCCESSFULLY TREATED THE PATIENT. THE WIRE FRAGMENT WAS LEFT IN THE PATIENT, MOST LIKELY TACKED UP WITH STENT. SUCCESSFUL CASE WITH MONGO ES TIP BREAKAGE BEING THE INCIDENT. NO INVESTIGATION IS NECESSARY. FACILITY DISCARDED DEVICE AND WAS NOT OVERLY CONCERNED. PLEASE ADVISE IF YOU NEED ANY OTHER INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 11486118 ↗