Gladiator™ Elite H74939207060870Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729809753), received between Oct 8, 2018 and Apr 2, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Fluid/Blood Leak; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12MAR2026. IT WAS REPORTED THAT BALLOON WAS UNABLE TO INFLATE. THE 53% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED BASILIC VEIN. A 6.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE INITIAL PRESSURIZATION TO 8 ATMOSPHERES, THE BALLOON COULD NOT MAINTAIN THE PRESSURE. THE BALLOON WAS WITHDRAWN FROM THE BODY, AND IT WAS FOUND THAT THE BALLOON WAS LEAKING LIQUID. NO PINHOLE WAS NOTED ON THE BALLOON MATERIAL. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24763910 ↗
• MalfunctionDec 12, 2025Fluid/Blood Leak; Inflation Problem; Material Rupture; Fluid/Blood Leak; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE BASILIC VEIN. A 6.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING PRESSURIZATION, IT WAS FOUND THAT THE BALLOON COULD NOT MAINTAIN PRESSURE. THE PRESSURE WAS IMMEDIATELY WITHDRAWN, AND THE BALLOON WAS REMOVED. AFTER EXAMINATION, IT WAS FOUND THAT THE BALLOON LEAKED LIQUID AND IT COULD NOT CONTINUE TO BE USED. 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 23796487 ↗
• MalfunctionAug 12, 2025Inflation Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Inflation Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21JUL2025. IT WAS REPORTED THAT BALLOON WAS UNABLE TO INFLATE, AND FLUID LEAK OCCURRED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ARTERIOVENOUS FISTULA OF UPPER LIMB. A 6.0 X80,75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING PRESSURIZATION, THE BALLOON COULD NOT BE INFLATED AT THE LESION SITE. THE BALLOON WAS REMOVED AND WHEN PRESSURIZED OUTSIDE THE BODY, FLUID LEAK OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A FULL BALLOON CIRCUMFERENTIAL TEAR WAS IDENTIFIED LOCATED APPROXIMATELY 40MM DISTAL OF THE PROXIMAL BALLOON MARKERBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784606 ↗
• MalfunctionJun 11, 2025Inflation Problem; Leak/Splash; Material Rupture; Inflation Problem; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT A BALLOON TEAR OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 6.0 X 80, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING INFLATION, THE BALLOON FAILED TO INFLATE UNDER PRESSURE. UPON WITHDRAWAL, EXTERNAL PRESSURIZATION REVEALED A VISIBLE TEAR ON THE BALLOON AND WAS LEAKING LIQUID. SUBSEQUENTLY, THE BALLOON WAS REPLACED WITH A SECOND 6 X 80 MM, 75 CM GLADIATOR BALLOON, BUT UPON PRESSURIZATION TO 10 ATMOSPHERES, THE BALLOON STILL FAILED TO INFLATE. THE PROCEDURE WAS COMPLETED WITH A 6 X 40 MM, 75 CM GLADIATOR BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE 70% STENOSED, MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22182963 ↗
• MalfunctionSep 12, 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. TWO 6.0 X80, 75CM GLADIATOR BALLOON CATHETERS WERE USED ON THE SAME PATIENT. THE FIRST BALLOON CROSSED THE GUIDEWIRE AND ENTERED THE STENOSIS LOCATED IN THE ARTERIOVENOUS GRAFT OF THE LEFT FOREARM. DURING THE PROCEDURE, ON THE FIRST INFLATION AT 10 ATMOSPHERES, THERE WAS LIQUID LEAKING, A RUPTURE OCCURRED. THE DEVICE WAS REMOVED AND REPLACED FOR THE SECOND GLADIATOR BALLOON, BUT AT 10 ATMOSPHERES, IT WAS LEAKING LIQUID AGAIN. ANOTHER OF THE SAME MODEL WAS USED TO CONTINUE THE PROCEDURE AND WAS PRESSURIZED AT 22 ATMOSPHERES. THE STENOSIS WAS DILATED AND THE PROCEDURE WAS PROCEEDED AND ENDED SUCCESSFULLY. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20204534 ↗
• MalfunctionSep 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. TWO 6.0 X80, 75CM GLADIATOR BALLOON CATHETERS WERE USED ON THE SAME PATIENT. THE FIRST BALLOON CROSSED THE GUIDEWIRE AND ENTERED THE STENOSIS LOCATED IN THE ARTERIOVENOUS GRAFT OF THE LEFT FOREARM. DURING THE PROCEDURE, ON THE FIRST INFLATION AT 10 ATMOSPHERES, THERE WAS LIQUID LEAKING, A RUPTURE OCCURRED. THE DEVICE WAS REMOVED AND REPLACED FOR THE SECOND GLADIATOR BALLOON, BUT AT 10 ATMOSPHERES, IT WAS LEAKING LIQUID AGAIN. ANOTHER OF THE SAME MODEL WAS USED TO CONTINUE THE PROCEDURE AND WAS PRESSURIZED AT 22 ATMOSPHERES. THE STENOSIS WAS DILATED AND THE PROCEDURE WAS PROCEEDED AND ENDED SUCCESSFULLY. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20203448 ↗
• MalfunctionJun 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 6.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS SELECTED FOR USE. WHILE PREPARING THE DEVICE, THE BALLOON PART FELL OUT FROM THE SHAFT BEFORE IT WAS INTRODUCED TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481190 ↗
• MalfunctionOct 30, 2023Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26OCT2023. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE OCCLUSIVE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND LIVER CIRRHOSIS HEPATIC PORTAL VEIN. A 6.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON REACHING THE LESION SITE, THE DEVICE BEGAN TO EXPAND UNDER PRESSURE AND WHEN REACHED TO 2 ATMOSPHERES, THE PRESSURE GAUGE COULD NOT CONTINUE TO HOLD PRESSURE. LEAKAGE OF THE BALLOON WAS THEN OBSERVED. THE DEVICE WAS SIMPLY REMOVED, VITRO TEST CONFIRMED THAT THE BALLOON LEAK LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT BALLOON HAD A PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035631 ↗
• MalfunctionMay 24, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED ARTERIAL ANASTOMOSIS AND ANASTOMOTIC SEGMENT OF THE LEFT ARM FISTULA. A 6.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON FAILED TO INFLATE, AND A LEAK WAS NOTED. WHEN THE DEVICE WAS CHECKED WITH SALINE, PINHOLE WAS DETECTED. THE DEVICE WAS REMOVED OVER THE WIRE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991680 ↗
• MalfunctionMar 16, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ARTERIOVENOUS FISTULA STENOSIS AND UNDERWENT PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. A 6.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON BROKE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16557470 ↗
• MalfunctionJun 28, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 6.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INITIAL INFLATION AT LESS WORKING PRESSURE FOR FEW SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14845245 ↗
• MalfunctionMar 8, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 6.0 X80, 75CM GLADIATOR 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 REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691348 ↗
• MalfunctionOct 23, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ELBOW. A 6.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING FIRST INFLATION AT 16 ATMOSPHERES, THE BALLOON BURSTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE 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 9224818 ↗
• MalfunctionOct 8, 2018Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN. A 6.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION AT 20 ATMOSPHERES THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7943294 ↗