ASAHI Gladius Mongo14 ES AP14R324SRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04547327123747), received between Feb 8, 2022 and Sep 10, 2026 — classified as 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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 16, 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.

• InjurySep 10, 2026Material Separation

  It was reported that an Asahi Gladius Mongo 14 ES guide wire was used during a plain old balloon angioplasty (POBA) to treat a heavily calcified, heavily tortuous chronic total occlusion (CTO) in the mid anterior tibial artery (ATA). The ATA was totally occluded throughout its entire length from the proximal segment. The Gladius Mongo 14 ES guide wire was advanced into the proximal ATA. While advancing the tip of the guide wire to make a small J shape, it got caught and entangled, forming a knot in one of the side branches of the ATA branching off the proximal segment. Subsequently, the entangled portion of the guide wire could not be unknotted and withdrawn. The tip of the Gladius Mongo 14 ES guide wire broke off within the small side branch of the ATA. After the tip fracture, the proximal segment of the Gladius Mongo 14 ES guide wire was successfully withdrawn from the patient anatomy. The separated wire tip remained in the patient anatomy and could not be retrieved. The physician commented that the tip of the guide wire became entangled and formed a knot as a result ofrapid advancement and rotation of the wire within an extremely narrow side branch of the ATA. The size of the kn

  Patient problems: Foreign Body In Patient

  MAUDE report 50722714 ↗
• InjurySep 9, 2026Material Separation

  It was reported that an Asahi Gladius Mongo 14 ES guide wire was used during a plain old balloon angioplasty (POBA) to treat a heavily calcified, heavily tortuous chronic total occlusion (CTO) in the mid anterior tibial artery (ATA). The ATA was totally occluded throughout its entire length from the proximal segment. The Gladius Mongo 14 ES guide wire was advanced into the proximal ATA. While advancing the tip of the guide wire to make a small J shape, it got caught and entangled, forming a knot in one of the side branches of the ATA branching off the proximal segment. Subsequently, the entangled portion of the guide wire could not be unknotted and withdrawn. The tip of the Gladius Mongo 14 ES guide wire broke off within the small side branch of the ATA. After the tip fracture, the proximal segment of the Gladius Mongo 14 ES guide wire was successfully withdrawn from the patient anatomy. The separated wire tip remained in the patient anatomy and could not be retrieved.The physician commented that the tip of the guide wire became entangled and formed a knot as a result of rapid advancement and rotation of the wire within an extremely narrow side branch of the ATA. The size of the kn

  Patient problems: Foreign Body In Patient

  MAUDE report 50683808 ↗
• InjuryJul 21, 2026Peeled/Delaminated

  IT WAS REPORTED THAT A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) WAS PERFORMED FOR A HEAVILY CALCIFIED LESION AT THE ORIGIN OF THE PERONEAL ARTERY. THE LESION WAS CROSSED WITH AN ASAHI GLADIUS MONGO 14 ES GUIDE WIRE. AFTER THE GLADIUS MONGO 14 ES GUIDE WIRE WAS REMOVED FOR WIRE EXCHANGE, PEELING OF THE POLYMER JACKET WAS OBSERVED, AND THE NEW GUIDE WIRE COULD NOT BE ADVANCED. THE DEVICE SYSTEM WAS THEN REMOVED AND THE PROCEDURE WAS RESTARTED. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS STABLE AFTER THE PROCEDURE. MFR REPORT #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25891167 ↗
• InjuryJul 21, 2026Peeled/Delaminated

  IT WAS REPORTED THAT AN ASAHI GLADIUS MONGO 14 ES GUIDE WIRE WAS USED DURING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) FOR AN UNSPECIFIED LESION. AFTER THE GLADIUS MONGO 14 ES GUIDE WIRE WAS REMOVED FOR WIRE EXCHANGE, PEELING OF THE POLYMER JACKET WAS OBSERVED, AND THE NEW GUIDE WIRE COULD NOT BE ADVANCED. THE DEVICE SYSTEM WAS THEN REMOVED AND THE PROCEDURE WAS RESTARTED. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS STABLE AFTER THE PROCEDURE. MFR REPORT #: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25890913 ↗
• InjuryJul 17, 2026Peeled/Delaminated

  IT WAS REPORTED THAT A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) WAS PERFORMED FOR A HEAVILY CALCIFIED LESION AT THE ORIGIN OF THE PERONEAL ARTERY. THE LESION WAS CROSSED WITH AN ASAHI GLADIUS MONGO 14 ES GUIDE WIRE. AFTER THE GLADIUS MONGO 14 ES GUIDE WIRE WAS REMOVED FOR WIRE EXCHANGE, PEELING OF THE POLYMER JACKET WAS OBSERVED, AND THE NEW GUIDE WIRE COULD NOT BE ADVANCED. THE DEVICE SYSTEM WAS THEN REMOVED AND THE PROCEDURE WAS RESTARTED. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25851291 ↗
• InjuryJun 13, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT AN ASAHI GLADIUS MG14 ES GUIDE WIRE WAS USED FOR REVASCULARIZATION OF A MILDLY CALCIFIED 100% OCCLUDED LESION IN THE ULNAR ARTERY. THE GUIDE WIRE WAS EXCESSIVELY TORQUED AND KNOTTED UP IN THE DISTAL ULNAR ARTERY. DURING REMOVAL ATTEMPTS, A DISTAL COIL SEGMENT WAS DETACHED FROM THE PROXIMAL SIDE AND LEFT IN THE PATIENT ANATOMY. THE PHYSICIAN CONCLUDED THAT THE WIRE FRAGMENT COULD BE LEFT IN SITU WITHOUT ISSUE. IT WAS INFORMED THAT THE PATIENT WAS DISCHARGED, WHOSE CONDITION WAS THE SAME AS THAT BEFORE THE PROCEDURE ALTHOUGH THE INTENDED REVASCULARIZATION WAS NOT ACHIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22200441 ↗
• MalfunctionMay 27, 2025Material Fragmentation; Material Fragmentation

  MONGO USED VIA ULNAR ARTERY TO ATTEMPT REVASCULARIZATION; WIRE WAS HEAVILY TORQUED AND "KNOTTED UP" IN THE DISTAL ULNAR ARTERY. WHEN ATTEMPTING TO REMOVE THE WIRE FROM THE ANATOMY, PART OF DISTAL COIL DETACHED FROM THE PROXIMAL COIL & WAS LEFT IN THE BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22092511 ↗
• MalfunctionSep 12, 2024Material Fragmentation; Material Fragmentation

  MD KNUCKLED WIRE WITH IN RCA CTO AND UPON REMOVING JACKETED PORTION CAME OFF CORE WIRE. THE JACKETED PORTION BROKE OFF IN THE SUBINTIMAL SPACE AND WAS UNRETRIEVABLE. THERE WAS NO SIDE EFFECTS. THEY WERE UNABLE TO CROSS DUE TO TOUGH CTO AND THE AMOUNT OF RADIATION, SO THE SECOND PROCEDURE WAS PERFORMED LATER. IN THE SECOND PROCEDURE, THE CTO WAS CROSSED FROM RETROGRADE APPROACH AND STENTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20207610 ↗
• MalfunctionSep 6, 2024Break; Break

  DR (B)(6) WAS TRYING TO NAVIGATE AN EXTREMELY CALCIFIED AT CTO WITH NO BLOOD FLOW. HE TRIED TRAVERSING AROUND THE SEGMENT AND WIRE BECAME STUCK AND WHEN HE TRIED TO ADVANCE ABOUT A 1CM PORTION OF THE DISTAL TIP CAME OFF. BECAUSE OF WHERE THE TIP BROKE AND NO FLOW IT WAS DETERMINED BY PHYSICIAN THAT LEAVING WHERE IT WAS WOULD NOT POSE ANY SORT OF RISK TO PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20158906 ↗
• InjurySep 1, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PERIPHERAL PERCUTANEOUS INTERVENTION (PPI) WAS PERFORMED FOR A HEAVILY CALCIFIED AND MODERATELY TORTUOUS CHRONIC TOTAL OCCLUSION (CTO) IN THE TIBIAL ARTERY (TA). WHEN AN ATTEMPT WAS MADE WITH AN ASAHI GLADIUS MONGO 14 ES GUIDE WIRE TO CROSS THE LESION, THE GUIDE WIRE WAS CAUGHT BY THE LESION. AS FURTHER ATTEMPTS WERE MADE TO ADVANCE THE GUIDE WIRE, IT BROKE OFF FOR APPROXIMATELY 1CM FROM THE WIRE TIP. HAVING CONSIDERED THAT THERE HAD BEEN NO FLOW IN THE SEGMENT WHERE THE WIRE WAS DETACHED, THE PHYSICIAN CONCLUDED THAT THE FRAGMENT COULD BE LEFT IN SITU AS THERE WOULD BE NO RISK TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT PROBLEM, AND THE PATIENT WAS DISCHARGED IN A FEW HOURS AFTER THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20115710 ↗
• InjuryJul 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) WAS PERFORMED TO TREAT THE RIGHT LOWER EXTREMITY FOR A PATIENT WHO HAD PERIPHERAL ARTERY DISEASE (PAD) AS WELL AS A HISTORY OF BELOW-THE-KNEE AMPUTATION OF THE LEFT LOWER EXTREMITY. ANGIOGRAPHY SHOWED MULTIPLE CALCIFIED LESIONS THROUGHOUT THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), POPLITEAL ARTERY, RIGHT TIBIOPERONEAL TRUNK EXTENDING THROUGHOUT RIGHT POST TIBIAL ARTERY (PTA). AN UNSPECIFIED SHEATH WAS INSERTED INTO THE RIGHT SFA VIA CONTRALATERAL APPROACH AND AN ASAHI GLADIUS MONGO14 ES GUIDE WIRE WAS USED AS THE INITIAL PERIPHERAL GUIDE WIRE. THE GUIDE WIRE WAS SUCCESSFULLY ADVANCED THROUGH SFA, POPLITEAL ARTERY AND TIBIOPERONEAL TRUNK TO THE PTA ; HOWEVER, THE GUIDE WIRE COULD NOT BE ANY FURTHER AFTERWARDS. IN ATTEMPTS TO CROSS THE LESION WITH ANOTHER GUIDE WIRE, AN ASAHI CROSSWALK MICROCATHETER WAS ADVANCED AND THE GLADIUS MONGO14 ES GUIDE WIRE WAS THEN REMOVED. UPON REVIEW OF THE REMOVED GLADIUS MONGO14 ES GUIDE WIRE, THE TIP OF THE GUIDE WIRE WAS FOUND DETACHED. ANGIOGRAPHY SHOWED THAT THE DETACHED WIRE TIP WAS LEFT IN THE DISTAL PTA AT THE BEGINNING OF THE CHRONIC TOTAL OCCLUSION (CTO). THE PHYSICIAN DETERMINE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19769155 ↗
• MalfunctionJul 11, 2024Fracture; Fracture

  SFA, POPLITEAL, RT TIBIOPERONEAL TRUNK EXTENDING THROUGHOUT RT POST TIBIAL ARTERY. CONTRALATERAL PLACEMENT OF SHEATH TO RT SFA COMPLETED AND MONGO14 ES USED AS INITIAL PERIPHERAL GUIDE WIRE. AFTER SUCCESSFULLY NAVIGATING THROUGH SFA, POPLITEAL AND TIBIOPERONEAL TRUNK AND MOST OF THE RT POST TIB. WIRE ADVANCEMENT WAS STOPPED, CROSSWALK ADVANCED AND MONGO WIRE WAS REMOVED WITH THE INTENT TO TRY ANOTHER WIRE TO ADVANCE. UPON REVIEW OF WIRE POST REMOVAL, THE TIP OF THE WIRE EXCLUDING THE CORE WAS STRIPPED FROM THE WIRE. UPON ANGIOGRAPHIC REVIEW, THE TIP OF WIRE WAS LEFT IN THE DISTAL POSTERIOR TIBIAL ARTERY AT THE BEGINNING OF THE CTO. THE PHYSICIAN AND I DISCUSSED THE FINDING AND HE STATED THAT IT WOULD CAUSE NO FURTHER HARM TO THE PATIENT BECAUSE OF THE EXISTING CTO.

  Patient problems: Foreign Body In Patient

  MAUDE report 19727324 ↗
• InjuryApr 15, 2024Material Fragmentation; Material Fragmentation

  ACCESSED THE ANTERIOR TIBIAL THEN ATTEMPTED TO CROSS THE OCCLUDED PROXIMAL AND MID ANTERIOR TIBIAL ARTERY OCCLUSION. AT PROXIMAL OCCLUSION AREA, WHEN TRYING TO WIRE INTO THE DISTAL SEGMENT OF THE POPLITEAL ARTERY, WE WERE SUBINTIMAL TRYING TO NAVIGATE BACK INTO THE NATIVE AND THE WIRE TIP BROKE OFF WHEN TRYING TO REMOVE WIRE FROM CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 19105409 ↗
• InjuryApr 4, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT AN ASAHI GLADIUS MONGO 14 ES GUIDE WIRE WAS USED TO CROSS A 100% OCCLUDED LESION IN THE MODERATELY CALCIFIED PROXIMAL TO MID SEGMENT OF THE ANTERIOR TIBIAL ARTERY. WHEN THE GLADIUS MONGO 14 ES GUIDE WIRE WAS ADVANCED TO THE DISTAL POPLITEAL ARTERY, THE GUIDE WIRE WENT INTO THE SUBINTIMAL SPACE IN THE PROXIMAL OCCLUDED LESION. WHILE ATTEMPTS WERE BEING MADE TO NAVIGATE BACK THE GUIDE WIRE TO THE TRUE LUMEN BY WITHDRAWING THE GUIDE WIRE FROM THE CONCOMITANT CATHETER, THE DISTAL SEGMENT OF THE GUIDE WIRE BROKE OFF. THE INTRAVASCULAR ULTRASOUND (IVUS) IMAGE REVEALED THAT THE WIRE FRAGMENT WAS LEFT IN THE SUBINTIMAL SPACE THE PHYSICIAN DECIDED THAT THE FRAGMENT COULD NOT BE SNARED OUT AND THEREFORE WOULD BE LEFT IN SITU. LASER ATHERECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WERE PERFORMED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH REESTABLISHED BLOOD FLOW. IT WAS INFORMED THAT THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THE EVENT, AND THE PATIENT WAS DISCHARGED AFTER THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19048084 ↗
• InjuryAug 31, 2023Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT AN ASAHI GLADIUS MONGO 14 ES GUIDE WIRE WAS USED DURING A PERCUTANEOUS PERIPHERAL INTERVENTION (PPI) TO TREAT A CALCIFIED TOTAL OCCLUSION IN THE PROXIMAL LEFT ANTERIOR TIBIAL ARTERY (ATA) VIA RETROGRADE APPROACH. THE GLADIUS MONGO 14 ES GUIDE WIRE WAS ADVANCED TO POSTERIOR TIBIAL ARTERY THROUGH THE PEDAL LOOP AND THEN CROSSED THE LESION IN THE ATA. WHEN AN ATTEMPT WAS MADE TO SNARE OUT THE GUIDE WIRE WITH A 6-10MM MERIT MEDICAL EN SNARE FOR WIRE EXTERNALIZATION, ONLY THE VERY DISTAL SEGMENT OF THE GUIDE WIRE COULD BE CAPTURED. HAVING BEEN PULLED FURTHER FOR EXTERNALIZATION, THE GUIDE WIRE STARTED TO UNRAVEL BUT WAS ABLE TO BE REMOVED SAFELY WITHOUT ANY ISSUES. THERE WAS NO WIRE FRAGMENT RETAINING IN THE PATIENT. A NEW GLADIUS MONGO 14 ES GUIDE WIRE WAS THEN USED TO RESUME THE PROCEDURE. LASER ATHERECTOMY AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) WERE PERFORMED TO SUCCESSFULLY REESTABLISH BLOOD FLOW. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS DISCHARGED TO HOME LATER IN THE AFTERNOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17659863 ↗
• MalfunctionAug 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  GLADIUS MONGO 14 ES WAS USED DOWN POSTERIOR TIBIAL THRU PEDAL LOOP TO GAIN ACCESS TO THE ANTERIOR TIBIAL ARTERY FROM THE RETROGRADE AND WAS IN THE PROCESS OF BEING SNARED OUT WITH A ENSNARE 6-10MM SNARE DEVICE FOR EXTERNALIZATION OF THE WIRE. SNARE ONLY CAPTURED THE VERY DISTAL TIP OF THE WIRE BEFORE PHYSICIAN STARTED TO PULL TO EXTERNALIZE WIRE. THE GLADIUS MONGO 14 ES STARTED TO UNRAVEL BUT WAS ABLE TO BE REMOVED SAFELY, WITHOUT INJURY OR INCIDENCE. NO FRAGMENTS WERE LEFT BEHIND AND A NEW GLADIUS MONGO 14 ES WAS OPENED AND REPLACED THE DAMAGED WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17510769 ↗
• MalfunctionAug 9, 2022Break

  WIRE BROKE OFF IN CALCIFIED R SFA.

  Patient problems: Foreign Body In Patient

  MAUDE report 15192171 ↗
• InjuryAug 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF AN ASAHI GLADIUS MONGO GUIDE WIRE HAD SEPARATED DURING RIGHT LOWER EXTREMITY ANGIOGRAM TO TREAT A HEAVILY CALCIFIED CHRONIC TOTAL OCCLUSION (CTO) IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). TARGET LESION WAS HEAVILY CALCIFIED, SO THERE WAS DIFFICULTY MOVING THE DEVICE THROUGH THE LESION. WHEN TRYING TO RETRACT THE WIRE BACK INTO THE NON-ASAHI QUICK-CROSS SUPPORT CATHETER, THE WIRE TIP SEPARATED IN THE HEAVILY CALCIFIED R SFA. NO ATTEMPT WAS MADE BECAUSE THERE WAS NO WAY TO RETRIEVE THE TIP DUE TO THE COMPLEXITY OF THE LESION. IT WAS UNABLE TO FIX THE PATIENT'S SFA DUE TO CALCIFIED PLAQUE BURDEN. PROCEDURE WAS ABANDONED DUE TO COMPLEXITY OF LESION. THE SEPARATED TIP IS STABLE AND WILL NOT BE MIGRATING. THERE WAS NO DELAY IN THE PROCEDURE DUE TO LOSING THE WIRE TIP. PATIENT OUTCOME UNCHANGED DUE TO THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 15189272 ↗
• InjuryFeb 8, 2022Peeled/Delaminated; Detachment of Device or Device Component; Peeled/Delaminated; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH UF REPORT # (B)(4) THAT COATING (MOST LIKELY POLYMER JACKET) OF AN ASAHI GLADIUS MONGO ES GUIDE WIRE PEELED OFF AND DISLODGED INTO A BRANCH OF THE RIGHT POSTERIOR TIBIAL ARTERY DURING ANGIOPLASTY OF THE RIGHT LOWER EXTREMITY. THE GUIDE WIRE WAS MANIPULATED THROUGH CALCIFIED VESSELS THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 13489336 ↗
• MalfunctionFeb 8, 2022Unraveled Material; Device Dislodged or Dislocated

  MONGO WIRE COATING ON THE TIP OF THE WIRE BECAME UNRAVELED AND DISLODGED INTO A BRANCH OF THE R POSTERIOR TIBIAL ARTERY.

  Patient problems: Insufficient Information

  MAUDE report 13481830 ↗