Gladiator™ Elite H74939207070870Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 08714729809838), received between Oct 2, 2018 and Apr 9, 2026 — classified as 1 injury, 39 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (36 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 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Fluid/Blood Leak

  REPORTABLE BASED ON HE DEVICE ANALYSIS COMPLETED ON 19MAR2026. IT WAS REPORTED THAT CATHETER LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION, WHEN THE BALLOON WAS PRESSURIZED TO 18 ATMOSPHERES, LEAKAGE OF FLUID FROM THE BALLOON WAS OBSERVED, AND THE DEVICE COULD NOT MAINTAIN PRESSURE. THE INFLATION WAS IMMEDIATELY STOPPED, AND THE BALLOON CATHETER WAS WITHDRAWN FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER BALLOON CATHETER OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24825676 ↗
• MalfunctionNov 6, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13OCT2025. IT WAS REPORTED THAT A BALLOON FAILED TO INFLATE AND LEAK OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILD CALCIFIED VESSEL. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON FAILED TO INFLATE AND WAS LEAKING LIQUID AFTER REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491162 ↗
• MalfunctionJul 30, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 7.0 X80,75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING PROCEDURE, THE BALLOON RUPTURED UPON SIX OR SEVEN INFLATIONS AT 20 ATMOSPHERES FOR ONE MINUTE. 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 22669240 ↗
• MalfunctionJul 29, 2025Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 80% TO 90% STENOSED, SEVERELY TORTUOUS AND SEVERELY CALCIFIED. THE BALLOON WAS INFLATED SIXTH TO SEVENTH TIMES AND WAS RUPTURED AT 20 ATMOSPHERES FOR 50 TO 60 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645007 ↗
• MalfunctionDec 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS BROKEN. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926485 ↗
• MalfunctionSep 20, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X80, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON BURST WITHOUT REACHING TO THE MAX RATED PRESSURE. NO FURTHER INFORMATION WAS REPORTED TO BOSTON SCIENTIFIC REGARDING THE PROCEDURE. NO COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ARTERIOVENOUS FISTULA. THE BALLOON WAS INFLATED ONCE AND TRIED TO INCREASE TO THE RATED BURST PRESSURE (RBP) UNTIL IT RUPTURED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE GLADIATOR BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20267444 ↗
• MalfunctionSep 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING INFLATION, THE BALLOON BURST WITHOUT REACHING TO THE MAXIMUM RATED PRESSURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255239 ↗
• MalfunctionMar 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X80, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 14 ATMOSPHERES FOR LESS THAN 20 SECONDS, THE BALLOON BURST. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18818328 ↗
• MalfunctionJul 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN INTERNAL ARTERIOVENOUS FISTULA. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360878 ↗
• MalfunctionDec 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED FOR BALLOON DILATION OF VASCULAR STENOSIS AT FISTULA. THE 50% STENOSED TARGET LESION WITH A BEND OF > 90DEGREES WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 15-20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED AND A PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THERE WERE TWO 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETERS USED DURING THE PROCEDURE AND WERE DAMAGED. THE BALLOON CATHETERS GOT DAMAGED ON THE SECOND TIME IT WAS PRESSURIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060222 ↗
• MalfunctionDec 22, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND MODERATELY CALCIFIED FISTULA. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT 15-20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND PINHOLE WAS FOUND IN THE MIDDLE AND NEAR THE PROXIMAL END OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THERE WERE TWO 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETERS USED DURING THE PROCEDURE AND WERE DAMAGED. THE BALLOON CATHETERS GOT DAMAGED ON THE SECOND TIME IT WAS PRESSURIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16038056 ↗
• MalfunctionDec 21, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON TEAR OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE ARTIFICIAL VESSEL NEAR ARTERIAL ANASTOMOSIS. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE THE BALLOON TORN WHEN PRESSURIZED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022289 ↗
• MalfunctionDec 14, 2022Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ARTERIOVENOUS FISTULA. A 7.0 X80, 75CM GLADIATOR CATHETER WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS BROKEN DURING PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON MATERIAL WAS BROKEN/PINHOLE WAS NOTED AND NOT THE SHAFT AS WHAT WAS PREVIOUSLY REPORTED. THE DEVICE WAS REMOVED THROUGH THE CATHETER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982298 ↗
• MalfunctionNov 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERIOVENOUS FISTULA. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING EIGHTH INFLATION FOR 20 ATMOSPHERES FOR 1 TO 3 MINUTES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713948 ↗
• MalfunctionSep 30, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN ARTERIOVENOUS FISTULA. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509425 ↗
• MalfunctionSep 19, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446138 ↗
• MalfunctionAug 12, 2022Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA IN A MILDLY TORTUOUS AND NON-CALCIFIED VESSEL. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING SECOND INFLATION AT 22 ATMOSPHERES FOR FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND A PINHOLE WAS NOTED ON THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENTS COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15217407 ↗
• MalfunctionJul 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AFTER A 7FR NON-BOSTON SCIENTIFIC (BSC) INTRODUCER SHEATH WAS INTRODUCED AND A 180CM NON-BSC GUIDEWIRE CROSSED THE LESION, A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 20 ATMOSPHERES (ATM), THE BALLOON RUPTURED. ANOTHER 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED AND INFLATED AT 16 ATM; BUT IT ALSO RUPTURED. BOTH BALLOONS WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 7X40 NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958454 ↗
• MalfunctionJul 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. AFTER A 7FR NON-BOSTON SCIENTIFIC (BSC) INTRODUCER SHEATH WAS INTRODUCED AND A 180CM NON-BSC GUIDEWIRE CROSSED THE LESION, A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 20 ATMOSPHERES (ATM), THE BALLOON RUPTURED. ANOTHER 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED AND INFLATED AT 16 ATM; BUT IT ALSO RUPTURED. BOTH BALLOONS WERE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 7X40 NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958453 ↗
• MalfunctionJun 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN ARTERIOVENOUS FISTULA. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14847531 ↗
• MalfunctionMar 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13655249 ↗
• MalfunctionMar 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13642432 ↗
• MalfunctionFeb 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 7.0 X80, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13620806 ↗
• MalfunctionJan 18, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA (AVF). A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13281050 ↗
• MalfunctionNov 26, 2021Material Rupture; Adverse Event Without Identified Device or Use Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 7.0 X80, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON BURST DURING PROCEDURE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12876569 ↗