Gladiator™ Elite H74939207070440Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729809784), received between Nov 23, 2018 and Sep 17, 2025 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (19 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED, REQUIRING INCISION FOR REMOVAL. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT UPPER LIMB VESSEL. A 7.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS PRESSURIZED AT 14 ATMOSPHERES DURING THE FIRST INFLATION FOR 30 SECONDS, THE BALLOON RUPTURED AND DISCONNECTED. THE COLOR ULTRASOUND SHOWED THAT THE BALLOON BROKE AT THE TAIL END INSIDE THE BLOOD VESSEL AND COULD NOT BE WITHDRAWN FROM THE BLOOD VESSEL SHEATH. THEREFORE, AN INCISION WAS MADE TO REMOVE THE REMAINING PART OF THE BALLOON FROM THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080053 ↗
• MalfunctionJun 25, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE UPPER LIMB. A 7.0 X40, 40CM GLADIATOR? ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION AFTER LEFT ARTERIOVENOUS FISTULIZATION UNDER ULTRASOUND GUIDANCE. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 20 ATMOSPHERES DUE TO THE THICKENING OF THE PATIENT'S BLOOD VESSEL INTIMA AND THE FORMATION OF SMALL SCAR TISSUE. THE RUPTURED BALLOON WAS IMMEDIATELY WITHDRAWN, AND ULTRASOUND SHOWED NO DAMAGE TO THE PATIENT'S BLOOD VESSEL. UPON DEVICE INSPECTION, NO MISSING PART WAS OBSERVED WITH THE BALLOON, BUT A LINEAR RUPTURE WAS NOTED. THE PROCEDURE WAS COMPLETED A NEW 7MM BALLON CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22333559 ↗
• MalfunctionApr 4, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL OF THE UPPER LIMB. A 7.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING SECOND INFLATION AT 14-15 ATMOSPHERES, THE BALLOON RUPTURED. THE BALLOON WAS COMPLETELY REMOVED FROM THE VASCULAR SHEATH IMMEDIATELY. 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 21778385 ↗
• MalfunctionMar 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS VASCULAR ACCESS. A 7.0 X40, 40CM GLADIATOR ELITE BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON BURST DURING FIRST INFLATION AT 14 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM USING THE NORMAL METHOD, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21709009 ↗
• MalfunctionOct 30, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURED OCCURRED. THE STENOSED TARGET LESION WAS IN AN ARTERIOVENOUS FISTULA THAT WAS POORLY FUNCTIONING WITH A MINIMUM DIAMETER OF 1.8 MM AND A RESISTANCE INDEX OF 0.7 LOCATED IN THE LEFT UPPER LIMB VESSEL. A 7.0 X40, 40CM GLADIATOR ELITE WAS ADVANCED OVER THE GUIDEWIRE FOR DILATATION. HOWEVER, DURING THE INFLATION AT 17 ATMOSPHERES, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE AND THE STENOSIS WAS RELIEVED. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 70% STENOSED, NON-TORTUOUS, AND NON-CALCIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20564158 ↗
• MalfunctionSep 26, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON WAS BROKEN. THE TARGET LESION WAS LOCATED IN THE RIGHT FOREARM A 7.0 X40, 40CM 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. 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 20312997 ↗
• MalfunctionJul 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT UPPER EXTREMITY. A 7.0 X40, 40CM GLADIATOR ELITE WAS SELECTED FOR BALLOON DILATATION OF LEFT UPPER LIMB ARTIFICIAL BLOOD VESSEL ARTERIOVENOUS FISTULA. DURING THE PROCEDURE, THE LOCATION OF THE LESION WAS DETERMINED UNDER THE GUIDANCE OF COLOR ULTRASOUND. THE BALLOON WAS ADVANCED ALONG THE GUIDEWIRE TO DILATE THE VENOUS STENOSIS OF THE ARTIFICIAL BLOOD VESSEL. HOWEVER, DURING THE SECOND 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. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19759733 ↗
• MalfunctionMay 20, 2024Material 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 NOT TOO STENOSED AND WAS NON-TORTUOUS AND NON-CALCIFIC. A 7.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. THIS WAS NOT USED TO POST-DILATE A PREVIOUSLY PLACED STENT. DURING THE PROCEDURE, ON THE SECOND INFLATION, BETWEEN 15 TO 20 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY RETRIEVED WITH NO FRAGMENTS LEFT INSIDE THE PATIENT AND WAS REPLACED FOR A DIFFERENT DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352293 ↗
• MalfunctionNov 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 20% STENOSED TARGET LESIONS WERE LOCATED IN AN ANASTOMOSIS IN THE MODERATELY TORTUOUS AND NON-CALCIFIED LEFT WRIST INTERNAL ARTERIOVENOUS FISTULA AND UPPER ARM VEIN. A 7.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 24 ATMOSPHERES FOR 40 SECONDS, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18064623 ↗
• MalfunctionMay 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 7.0 X40, 40CM 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 WAS STABLE POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE 80% STENOSED TARGET LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED. THE BALLOON RUPTURED DURING THE SIXTH INFLATION AT 20 ATMOSPHERES FOR 40-50 SECONDS. NEITHER A BALLOON NOR A SEGMENT OF THE BALLOON DETACHED INSIDE THE PATIENT AFTER IT RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17021351 ↗
• MalfunctionAug 10, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT UPPER EXTREMITY. A 7.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED FIRST AT 20 ATMOSPHERES (ATM) BUT THE STENOSIS WAS NOT RESOLVED. WHEN IT WAS INFLATED FOR THE SECOND TIME AT 18 ATM, THE BALLOON BURST. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS OR INJURIES REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15198800 ↗
• MalfunctionJul 15, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 7.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT LESS WORKING PRESSURE FOR FEW SECONDS, THE BALLOON BURST. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15032978 ↗
• MalfunctionJun 8, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PERFORMED BALLOON DILATION BECAUSE OF INTERNAL FISTULA FUNCTIONAL DEFECT. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED VESSEL. A 7.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE CATHETER WAS FRACTURED. THE DEVICE WAS SIMPLY REMOVED AS A WHOLE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633701 ↗
• MalfunctionJun 2, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN A VESSEL IN THE ARM. A 7.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST WITHOUT REACHING THE RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575406 ↗
• MalfunctionJan 26, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL OF THE LEFT UPPER EXTREMITY. A 7.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 24 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359375 ↗
• MalfunctionAug 4, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE >50% STENOSED TARGET LESION WAS LOCATED IN A FISTULA. A 7.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT 20 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10365087 ↗
• MalfunctionMay 26, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 7.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, ON INITIAL INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10085972 ↗
• InjuryFeb 25, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND VESSEL HEMATOMA OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS ARTERIOVENOUS FISTULA IN AN UPPER LIMB. A 7.0 X 40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION AT 24 ATMOSPHERES, THE BALLOON RUPTURE. THE VESSEL WAS DAMAGED AND IMMEDIATELY FORMED HEMATOMA. THE PHYSICIAN USED ANOTHER OF THE SAME BALLOON TO TREAT THE HEMATOMA AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: Hematoma

  MAUDE report 8368086 ↗
• MalfunctionNov 26, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS INTERNAL FISTULA. A 7.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION AT 18 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8100835 ↗
• MalfunctionNov 23, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN INTERNAL FISTULA WITH A BLOOD FLOW RATE LESS THAN 160 ML PER MINUTE. A 7.0 X40, 40 CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE THE BALLOON FAILED TO DILATE THE LESION TWICE, THEN AT 22 ATMOSPHERES, IT WAS NOTED THAT THE PRESSURE PUMP WAS POINTING AT ZERO. THE PHYSICIAN REMOVED THE BALLOON AND INJECTED SALINE INTO IT. THE BALLOON WAS LEAKING AND NOTED TO BE RUPTURED. THE PROCEDURE WAS DISCONTINUED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8099818 ↗