Gladiator™ Elite H74939207120470Recalls & reported problems

Summary

The FDA's MAUDE database contains 69 adverse event reports that list this exact device (DI 08714729809555), received between Sep 24, 2018 and Aug 17, 2026 — classified as 1 injury, 68 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (55 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 25 most recent of 69 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Inflation Problem; Nonstandard Device; Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278483 ↗
• MalfunctionAug 18, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE INTERNAL FISTULA. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON RUPTURED DURING INSERTION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22825999 ↗
• MalfunctionAug 18, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24JUL2025. IT WAS REPORTED THAT THE BALLOON LEAKED AND COULD NOT BE PRESSURIZED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED LEFT SUBCLAVIAN VEIN. A 12.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS PRESSURIZED DURING THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON BEGAN TO LEAK LIQUID, AND IT COULD NOT CONTINUE TO PRESSURIZE. THE DEVICE WAS REMOVED, AND THERE WAS NO PHYSICAL DAMAGE NOTED TO THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22824989 ↗
• InjuryJan 27, 2025Difficult to Remove; Material Rupture; Detachment of Device or Device Component; Difficult to Remove; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON RUPTURED AND BECAME CAUGHT IN STENT, REQUIRING ADDITIONAL INTERVENTIONS FOR REMOVAL. THE TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS (ISR) LOCATED IN THE SUBCLAVIAN VEIN. A 12.0 X40, 75CM GLADIATOR ELITE WAS SELECTED FOR ANGIOPLASTY. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON RUPTURED AND BECAME CAUGHT IN STENT. UPON ATTEMPTING TO REMOVE THE BALLOON, IT BECAME DETACHED AT THE PROXIMAL END OF THE BALLOON, WHERE IT IS FIXED TO THE DELIVERY SHAFT, AND BECAME AN EMBOLUS. THE PHYSICIAN ATTEMPTED TO SNARE BUT WAS UNABLE TO PROPERLY VISUALIZE THE BALLOON ONCE IT BECAME DETACHED. THE PATIENT WAS THEN ESCALATED TO HOSPITAL TRANSFER FOR FURTHER INTERVENTION USING CT GUIDANCE BY AN INTERVENTIONAL RADIOLOGIST (IR). THE DETACHED FRAGMENTS WERE RECOVERED UNDER CT GUIDANCE, AND THE PATIENT FULLY RECOVERED.

  Patient problems: Embolism/Embolus

  MAUDE report 21246301 ↗
• MalfunctionMay 13, 2024Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60 % STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 12.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, WHEN THE BALLOON WAS PRESSURIZED AT 3-4 ATMOSPHERES, THE BALLOON DID NOT INFLATE AND WHEN REMOVED IT LOOKED LIKE THE BALLOON WAS LEAKING AT THE BONDING POINT ON THE DISTAL END. CONSEQUENTLY, A VISIBLE PINHOLE WAS NOTED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME SIZE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299047 ↗
• MalfunctionMar 28, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE VESSEL. A 12.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 3 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18998565 ↗
• MalfunctionMar 22, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-CALCIFIED SUBCLAVIAN ARTERY. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON ITS SECOND INFLATION AT 14 ATMOSPHERES. IT DID NOT REMAIN INFLATED DURING THE SECOND INFLATION. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961554 ↗
• MalfunctionFeb 16, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED ARTERY. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 14 ATMOSPHERES, THE BALLOON WOULD NOT HOLD ITS PRESSURE AS THE TIP OF THE BALLOON HAD A HOLE. THE DEVICE WAS REMOVED AND INSPECTED, AND THE LEAK WAS CONFIRMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER GLADIATOR ELITE BALLOON. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18721379 ↗
• MalfunctionFeb 14, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED ARTERY. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED IMMEDIATELY UPON FIRST INFLATION AT 14 ATMOSPHERES. THE DEVICE WAS PULLED OUT SUCCESSFULLY FROM THE PATIENT AND THERE WERE NO FRAGMENTS LEFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18705925 ↗
• MalfunctionFeb 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 12.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR POST DILATATION OF A PREVIOUSLY PLACED STENT. HOWEVER, DURING FIRST INFLATION AT 12 ATMOSPHERES, THE BALLOON BURST IMMEDIATELY. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18621418 ↗
• MalfunctionNov 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUBCLAVIAN ARTERY. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON REACHING 14 ATMOSPHERES. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER GLADIATOR BALLOON. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196331 ↗
• MalfunctionDec 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15974571 ↗
• MalfunctionSep 29, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED SUBCLAVIAN VEIN. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON BURST. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503364 ↗
• MalfunctionJul 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH PAIN IN AN INTERNAL FISTULA IN THE LEFT UPPER ARM ACCOMPANIED BY INCREASED VENOUS PRESSURE DURING DIALYSIS. ULTRASOUND REVEALED STENOSIS AND CALCIFICATION OF THE AUTOLOGOUS ARTERIOVENOUS INTERNAL FISTULA ANASTOMOSIS OSTIAL OF THE LEFT ELBOW, AND STENOSIS IN THE DISTAL END OF THE STENT OF THE SUBCLAVIAN VEIN. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 4 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103853 ↗
• MalfunctionMar 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS (AV) FISTULA IN THE MODERATELY TO SEVERELY CALCIFIED LEFT UPPER VESSEL. A 12.0 X 40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13766408 ↗
• MalfunctionDec 13, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED VESSE IN THE UPPER EXTREMITY. A 12.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12987398 ↗
• MalfunctionDec 6, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTIFICIAL ARTERIOVENOUS FISTULA. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12935025 ↗
• MalfunctionNov 1, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14OCT2021. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION THE BALLOON LEAKED WHEN TESTING IT WITH WATER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12727983 ↗
• MalfunctionAug 5, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CEPHALIC ARC. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED ALMOST FULLY EFFACING THE LESION. 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 12281098 ↗
• MalfunctionJun 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED BRACHIAL ARTERY. A 12.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED. HOWEVER, DURING FIRST INFLATION AT 10 ATMOSPHERES FOR 20 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11947745 ↗
• MalfunctionApr 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY VEIN. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR POST DILATION. HOWEVER, ON INITIAL INFLATION AT LESS WORKING PRESSURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736556 ↗
• MalfunctionApr 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A LOWER EXTREMITY VEIN. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, ON INITIAL INFLATION AT LESS WORKING PRESSURE FOR FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736549 ↗
• MalfunctionApr 16, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION; HOWEVER, THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11679319 ↗
• MalfunctionMar 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PARTIALLY STENOSED TARGET LESION WAS LOCATED IN THE SUPERIOR VENA CAVA. AFTER INSERTING A 10F INTRODUCER SHEATH, A 12.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, IT WAS FOUND THAT THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11554340 ↗
• MalfunctionMar 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CENTRAL VEIN. A 12.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED AT LESS THAN WORKING PRESSURE FOR FEW SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11432991 ↗