Gladiator™ Elite H74939207100470Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 08714729809517), received between Sep 25, 2018 and Mar 3, 2026 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (44 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 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE LOWER ARM. A 10.0 X 40, 75 CM GLADIATOR ELITE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES, THE DEVICE DID NOT HOLD PRESSURE AND RUPTURED IMMEDIATELY. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24503120 ↗
• MalfunctionFeb 16, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X40, 75CM GLADIATOR? ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 8 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 24349878 ↗
• MalfunctionFeb 4, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A VERY FIBROTIC ARTERIOVENOUS FISTULA. A 10.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INFLATION, THE BALLOON RUPTURED WITHOUT REACHING THE RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24262117 ↗
• MalfunctionJan 30, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X40, 75CM GLADIATOR? ELITE BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED DURING IN-STENT INFLATION AFTER THE FIRST INFLATION AT 14 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE USED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24228361 ↗
• MalfunctionJul 7, 2025Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, UPON REACHING THE NOMINAL PRESSURE OF 14 ATMOSPHERES, CONTRAST LEAKAGE WAS OBSERVED FLOWING BACK TOWARDS THE SHEATH. ADDITIONALLY, THE BALLOON RUPTURED DURING ITS INITIAL INFLATION. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22420707 ↗
• MalfunctionJun 16, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE RADIAL ARTERY ANASTOMOSIS. A 10.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 19 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, 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 22210018 ↗
• MalfunctionJun 11, 2025Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23MAY2025. IT WAS REPORTED THAT AIR LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT FOREARM. A 10.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, AN AIR LEAKAGE AT THE TIP OF THE BALLOON WAS NOTED WHEN THE PRESSURE REACHED AT 7 ATMOSPHERES. THE BALLOON WAS REPLACED WITH ANOTHER 10X4, AND THE PROCEDURE WAS COMPLETED AFTER NORMAL DILATION. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22189143 ↗
• MalfunctionMar 11, 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 MORE THAN 50% STENOSED TARGET LESION WAS LOCATED IN THE RADIAL ARTERY ANASTOMOSIS. A 10.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATION. THE BALLOON WAS PRESSURIZED TO 19 ATMOSPHERES IN THE VESSEL AND THE PRESSURE WAS DEPLOYED. WHEN REMOVED, IT WAS NOTED THAT THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE LESION WAS MODERATELY TORTUOUS AND MILDLY CALCIFIED. THE BALLOON WAS INFLATED FOR ABOVE 60 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572535 ↗
• MalfunctionFeb 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. PATIENT WAS PRESENTED WITH AN INNOMINATE VEIN STENOSIS. A 10.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED INTACT FROM THE PATIENT AND 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 21434945 ↗
• MalfunctionJan 10, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE RIGHT SUBCLAVIAN AND BRACHIOCEPHALIC VEINS. A 10.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON WAS RUPTURED AT 8 ATMOSPHERES. 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 21123785 ↗
• MalfunctionNov 19, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 8 ATMOSPHERES FOR LESS THAN 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20729028 ↗
• MalfunctionNov 13, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL IN THE ARM. A 10.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR ARM ANGIOPLASTY. DURING THE PROCEDURE, THE BALLOON RUPTURED ON INITIAL INFLATION AT 8 ATMOSPHERES FOR LESS THAN A SECOND. THE BALLOON BROKE LONGITUDINALLY. THE DEVICE WAS REMOVED WITHOUT ANY FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20672452 ↗
• MalfunctionJul 29, 2024Inflation Problem; Material Rupture; Material Integrity Problem; Inflation Problem; Material Rupture; Material Integrity Problem

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL IN THE ARM. A 10.0 X40, 75CM GLADIATOR ELITE WAS SELECTED FOR ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS DAMAGED AND HAD BURST. 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 19850227 ↗
• MalfunctionJan 15, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS IN THE LEFT PROXIMAL CEPHALIC VEIN. A 10.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION AT 10 ATMOSPHERES THE BALLOON RUPTURED. THE DEVICE WAS REMOVED 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 18513884 ↗
• MalfunctionOct 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION BEFORE REACHING THE MAXIMUM PRESSURE, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17956232 ↗
• MalfunctionSep 22, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH CEPHALIC ARCH STENOSIS AND UNDERWENT FISTULAGRAM. A 10.0 X 40, 75 CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 14 ATMOSPHERES, 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 17799379 ↗
• MalfunctionJun 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE RIGHT INNOMINATE VEIN. A 10.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED AT 14 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 60% STENOSED, NON-TORTUOUS AND CALCIFIED. THE BALLOON RUPTURED ON THE FIRST INFLATION AT 14 ATMOSPHERES FOR 30 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17206933 ↗
• MalfunctionJun 19, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT INNOMINATE VEIN. A 10.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 13 ATMOSPHERES FOR 10 TO 20 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17151895 ↗
• MalfunctionJan 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTRA STENT CEPHALIC ARCH. A 10.0 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 AND 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 13253012 ↗
• MalfunctionMar 17, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED BEFORE REACHING RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11505873 ↗
• MalfunctionFeb 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334727 ↗
• MalfunctionFeb 16, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334721 ↗
• MalfunctionOct 22, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT BALLOON SHAFT HOLE OCCURRED. A 10.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON HAD A SMALL HOLE AT THE BASE OF THE SHAFT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722203 ↗
• MalfunctionAug 28, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT FOREARM. A 10.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 14 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10469302 ↗
• MalfunctionAug 7, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN. A 10.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION AT 13 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10382846 ↗