Gladiator™ Elite H74939207040470Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729809616), received between Jan 6, 2023 and Mar 26, 2026 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (16 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CEPHALIC VEIN. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 26 ATMOSPHERES FOR 15 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THIS EVENT RESULTED IN PROLONGED OPERATION TIME AND INCREASED PATIENT DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 24700153 ↗
• MalfunctionOct 9, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ANASTOMOTIC STOMA OF THE NATIVE ARTERIOVENOUS FISTULA. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT LESS THAN 6 ATMOSPHERES. 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 23259643 ↗
• MalfunctionJul 21, 2025Inflation Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND SEVERELY CALCIFIED CEPHALIC VEIN. A 4.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED ACCOMPANIED BY A SQUEAKING SOUND UPON FIRST INFLATION AT 12 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 22553128 ↗
• MalfunctionMay 2, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT ARM. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON WAS SELECTED FOR USE. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 10 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. IT WAS FURTHER NOTED THAT 45% OF THE BRACHIAL ARTERY ON THE LEFT SIDE EXHIBITED MODERATE TORTUOSITY AND MILD CALCIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21955452 ↗
• MalfunctionFeb 21, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED VENA CEPHALICA ANTEBRACHII. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION AT 19 ATMOSPHERES, THE PRESSURE COULD NOT CONTINUE TO INCREASE AND THE BALLOON BURST. 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 21434931 ↗
• MalfunctionNov 4, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS VESSEL IN THE FOREARM. A 4.0 X40, 75CM GLADIATOR ELITE WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 24 ATMOSPHERES FOR 60 SECONDS, THE BALLOON BURST. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20597262 ↗
• MalfunctionOct 30, 2024Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE BALLOON WAS DAMAGED. THE STENOSED TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS POSITIONED AT THE LESION SITE, CONNECTED TO THE PUMP AND PRESSURIZED TO 18 ATMOSPHERES, BUT NO FURTHER INCREASE WAS POSSIBLE. WHEN THE BALLOON WAS WITHDRAWN AND PRESSURE REAPPLIED, IT WAS FOUND TO BE DAMAGED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH THIS 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 20565942 ↗
• MalfunctionSep 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE LEFT FOREARM VEIN. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, AFTER CONNECTING THE PRESSURE PUMP AND ATTEMPTING TO INFLATE THE BALLOON, THE PRESSURE SUDDENLY DROPPED, INDICATING THAT THE BALLOON HAD BROKEN AND RETRACTED. IT WAS NOTED THAT THE BALLOON HAD LONGITUDINAL TEARS AND WAS DIFFICULT TO WITHDRAW. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20316847 ↗
• MalfunctionJul 30, 2024Material Rupture; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Rupture; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT BALLOON RUPTURED AND TIP DAMAGED OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE LEFT UPPER EXTREMITY VESSEL. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS INFLATED FOR APPROXIMATELY 30 TO 60 SECONDS AT 22 TO 24 ATMOSPHERES FOR THE SECOND TIME. IT WAS DISCOVERED THAT THE BALLOON HAD RUPTURED. UPON REMOVAL, IT WAS OBSERVED THAT THE TIP OF THE BALLOON WAS BROKEN. THE PROCEDURE WAS THEN COMPLETED USING ANOTHER THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED WAS 78% STENOSED AND WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT UPPER EXTREMITY VESSEL. ADDITIONALLY, IT WAS NOTED THAT NO TIP FRACTURE OR DETACHMENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19867984 ↗
• MalfunctionMay 15, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6)2024. IT WAS REPORTED THAT BALLOON LEAKAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN. A 4.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, PRESSURE WAS APPLIED AT APPROXIMATELY 12 ATMOSPHERES, BUT IT WAS OBSERVED THAT THE PRESSURE COULDN'T BE SUSTAINED AND BEGAN TO DROP. SUBSEQUENTLY, UPON REMOVAL OF THE DEVICE, IT WAS OBSERVED THAT THE BALLOON HAD A LEAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A CIRCUMFERENTIAL TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19322887 ↗
• MalfunctionFeb 6, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS IN THE LEFT UPPER EXTREMITY. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON WAS SELECTED TO DILATE THE ARTIFICIAL BLOOD VESSEL. DURING THE PROCEDURE, THE BALLOON WAS INTRODUCED INTO THE VENOUS STENOSIS OF THE ARTIFICIAL BLOOD VESSEL ALONG THE GUIDEWIRE AND DILATED UNDER 10-22 ATMOSPHERES TWICE. AFTER 30-60 SECONDS, THE BLOOD VESSEL WAS DILATED UNDER 22-24 ATMOSPHERES FOR THE SECOND TIME. IT WAS FOUND THAT THE PRESSURE DECREASED, AND IT WAS CONSIDERED THAT THE BALLOON WAS BROKEN. AFTER THE BALLOON WAS PULLED OUT, IT WAS FOUND THAT THE BALLOON WAS RUPTURED LATERALLY. THEREFORE, THE BALLOON WAS REPLACED WITH ONE OF ANOTHER BRAND FOR BALLOON DILATION. THE PATIENT RECOVERED WELL AFTER PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651039 ↗
• MalfunctionNov 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE INTERNAL ARTERIOVENOUS FISTULA. A 4.0 X40, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE BALLOON WOULD NOT INFLATE FROM THE INCREASING PRESSURE. THE BALLOON WAS REMOVED FOR A TEST ON PRESSURE INCREASE AND IT WAS DISCOVERED THAT THERE WAS A SMALL HOLE AT THE TIP OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18217130 ↗
• InjurySep 14, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED FOREARM ARTERY. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED DURING OPEN HEART PROCEDURE 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 17748761 ↗
• MalfunctionAug 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED FOREARM VESSEL. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 20 ATMOSPHERES FOR 30 SECONDS, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17652194 ↗
• MalfunctionJun 27, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED INTERNAL FISTULA IN LEFT UPPER EXTREMITY. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS ABLE TO CROSS THE LESION; HOWEVER, DURING INFLATION AT 24 ATMOSPHERES, THE BALLOON MATERIAL BURST. 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 17209976 ↗
• MalfunctionMar 21, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, IT WAS NOTED THAT THE BALLOON BURST ALONG THE BALLOON SHAFT LENGTH WITHOUT REACHING THE MAXIMUM BURST PRESSURE OF BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16582886 ↗
• MalfunctionJan 6, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED ARTIFICIAL ARTERIOVENOUS FISTULA. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING PROCEDURE, THE BALLOON MATERIAL BROKE. 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 16117648 ↗