Gladiator™ Elite H74939207080870Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729809913), received between Jun 13, 2019 and Jan 8, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 58% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUBCLAVIAN VEIN. DURING THE PERCUTANEOUS ARTERIOVENOUS BALLOON DILATATION PROCEDURE, THE GUIDEWIRE CROSSED THE STENOTIC SEGMENT SMOOTHLY, AND AN 8.0 X 80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ACCURATELY DELIVERED TO THE LESION. THE BALLOON FULLY COVERED THE STENOSED PORTION OF THE SUBCLAVIAN VEIN. THE FIRST INFLATION WAS PERFORMED SUCCESSFULLY WITH NORMAL PRESSURE EXPANSION. DURING THE SECOND DILATION, THE BALLOON WAS PRESSURIZED TO 8 ATM AND INFLATED NORMALLY; HOWEVER, WHEN THE PRESSURE WAS INCREASED TO 12 ATM, THE BALLOON WAS UNABLE TO MAINTAIN PRESSURE AND SUBSEQUENTLY RUPTURED. THE OPERATOR IMMEDIATELY DEFLATED AND REMOVED THE DEVICE FROM THE BODY. UPON INSPECTION, LIQUID LEAKAGE WAS NOTED FROM THE BALLOON, CONFIRMING RUPTURE AND RENDERING THE DEVICE UNUSABLE. THERE WERE NO CHALLENGING ANATOMICAL FEATURES AND NO PATIENT-RELATED FACTORS THAT CONTRIBUTED TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003491 ↗
• MalfunctionOct 3, 2025Difficult to Remove; Stretched; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Stretched; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE CATHETER WAS DIFFICULT TO REMOVE. THE TARGET LESION WAS LOCATED IN THE PERIPHERAL ARTERY. AN 8.0 X80, 75CM GLADIATOR ELITE BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON REMOVAL THE CATHETER WAS DIFFICULT TO REMOVE AND WAS STRETCHING. THE BALLOON WAS DEFLATED AND WAS ABLE TO BE REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23210344 ↗
• MalfunctionMay 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON POPPED OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 8.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR FISTULOGRAM PROCEDURE. DURING THE PROCEDURE, THE BALLOON POPPED AT SECOND INFLATION. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT LEAVING ANY FRAGMENTS IN THE BODY, AND THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22092114 ↗
• MalfunctionOct 11, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AN 8.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST. THE DEVICE WAS SUCCESSFULLY REMOVED AND NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20429450 ↗
• MalfunctionJul 3, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE ATRIOVENTRICULAR FISTULA BRACHIAL CEPHALIC. A 8.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669384 ↗
• MalfunctionMar 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. AN 8.0 X80, 75CM GLADIATOR ELITE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 20 SECONDS, THE BALLOON BURST. ANOTHER BALLOON OF THE SAME SPECIFICATION WAS ATTEMPTED TO BE INFLATED, BUT IT BURST AGAIN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918228 ↗
• MalfunctionMar 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON BURST OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. AN 8.0 X80, 75CM GLADIATOR ELITE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES FOR 20 SECONDS, THE BALLOON BURST. ANOTHER BALLOON OF THE SAME SPECIFICATION WAS ATTEMPTED TO BE INFLATED, BUT IT BURST AGAIN. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918225 ↗
• MalfunctionJan 12, 2024Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AN 8.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS USED DURING A THROMBECTOMY PROCEDURE. HOWEVER, DURING THE PROCEDURE, THE DEVICE ALMOST FRACTURED. THE DEVICE WAS REMOVED SLOWLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON CATHETER DID NOT BREAK INTO PIECES AND WAS RETRIEVED IN ONE PIECE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18502620 ↗
• MalfunctionFeb 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS ARTERY. A 8.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON FAILED TO INFLATE. AFTER REMOVAL, IT WAS NOTICED THAT THE BALLOON WAS SLIGHTLY LEAKING, AND UPON FURTHER INSPECTION, A PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16370804 ↗
• MalfunctionSep 30, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A FISTULA. A 8.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT WHEN GOING IN AND OUT WITH THE BALLOON OVER THE NON-BOSTON SCIENTIFIC WIRE, IT DID NOT FEEL COMPLETELY SMOOTH LIKE NORMAL. AND DURING REMOVAL, IT WAS NOTED THAT THE WIRE FRAYED AND CAME APART, AND THE BALLOON CATHETER BECAME STUCK WITH THE WIRE. BOTH THE WIRE AND THE BALLOON CATHETER WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15513922 ↗
• MalfunctionSep 5, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VENOUS ANASTOMOSIS. A 8.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS ASPIRATED AND REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER 8X80 GLADIATOR DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15357706 ↗
• MalfunctionJul 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED VENOUS ANASTOMOSIS. AN 8.0 X80, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 10 ATMOSPHERES FOR 2 SECONDS, THE BALLOON RUPTURED. THE BALLOON WAS DEFLATED AND REMOVED SUCCESSFULLY WITH ALL OF THE BALLOON INTACT. ANOTHER 8 X 80 GLADIATOR BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15088982 ↗
• MalfunctionJul 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 8.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958415 ↗
• MalfunctionJun 6, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A VENOUS ANASTOMOSIS IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL IN THE LEFT ARM. A 8.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES FOR 1 SECOND, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605486 ↗
• MalfunctionMar 12, 2021Break; Deflation Problem; Break; Deflation Problem

  IT WAS REPORTED THAT SHAFT BREAK AND BALLOON DEFLATION FAILURE OCCURRED. A 8.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON WAS DIFFICULT TO DEFLATE, SO THE PHYSICIAN REMOVED BOTH THE BALLOON AND THE SHEATH. UPON REMOVAL, THE SHAFT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474388 ↗
• MalfunctionMar 23, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT HAD ILIAC VENOUS COMPRESSION SYNDROME. VASCULAR ACCESS WAS GAINED VIA THE LEFT ILIAC FEMORAL VEIN THROUGH THE LEFT ANTERIOR TIBIAL VEINS. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 8.0 X80, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING INFLATION AT 8 ATMOSPHERES (ATM). THE BALLOON RUPTURED AND BLOOD FLOWED BACK TO THE PUMP. SO, A 10.0 X80, 75CM CHARGER BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, DURING INFLATION AT 9 ATM, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 10.0 X80, 75CM CHARGER BALLOON CATHETER. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9868248 ↗
• MalfunctionJun 13, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A NON-CALCIFIED LEFT ARM GRAFT. A 8.0MM X 80MM, 75CM GLADIATEOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 2 ATMOSPHERES FOR 1 SECOND, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8698182 ↗