Gladiator™ Elite H74939207050440Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729809661), received between Aug 11, 2020 and Jul 3, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ORAL VEIN NEAR THE FISTULA. A 5.0 X40, 40CM GLADIATOR ELITE WAS SELECTED FOR DILATATION. UPON UNPACKING, IT WAS DISCOVERED THAT THE BALLOON HAD ALREADY RUPTURED. THIS EVENT DID NOT RESULT IN ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22399154 ↗
• MalfunctionJun 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON HAD A HOLE. THE 74% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT UPPER LIMB. A 5.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR PERCUTANEOUS VENOUS DILATION ALONG WITH THE GUIDEWIRE. THE PHYSICIAN CONNECTED THE PRESSURE PUMP AND INITIALLY PRESSURIZED THE BALLOON TO 2.3 ATMOSPHERES. HOWEVER, THE BALLOON DID NOT INFLATE. THE DEVICE WAS WITHDRAWN FROM THE BODY AND FOUND THAT THE BALLOON HAD A HOLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22256056 ↗
• MalfunctionDec 3, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. A 5.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, WHEN THE BALLOON WAS FULLY INFLATED, OOZING BLOOD FLOWED INTO THE PRESSURE PUMP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT NO PINHOLE WAS NOTED IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834041 ↗
• MalfunctionSep 3, 2024Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08-AUG-2024 IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VASCULAR ACCESS. A 5.0 X40, 40CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON WAS DAMAGED WHEN GIVING PRESSURE AND WAS REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR IN THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130211 ↗
• MalfunctionJan 17, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE LEFT UPPER EXTREMITY. A 5.0 X40, 40CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 23 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS NON-TORTUOUS AND NON-CALCIFIED. THE BALLOON FIRST PRESSURED AT 20 ATMOSPHERES, BUT THE STENOSIS WAS NOT DILATED. IT BURST WHEN PRESSURE WAS FURTHERED AT 23 ATMOSPHERES. THE BALLOON RUPTURED DURING THE FIRST INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18523640 ↗
• MalfunctionDec 21, 2023Inflation Problem; Leak/Splash; Material Integrity Problem; Inflation Problem; Leak/Splash; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30NOV2023. IT WAS REPORTED THAT BALLOON ISSUES OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS INTERNAL ARTERIOVENOUS FISTULA. A 5.0X40, 40CM GLADIATOR ELITE BALLOON CATHETER SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE BALLOON WAS FOUND LEAKING WITH LIQUID WHEN IT WAS PRESSURIZED, AND BALLOON COULD NOT BE DILATED. A MARK OF DAMAGE WAS NOTED IN THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT'S STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A BALLOON TEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373077 ↗
• MalfunctionApr 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED FOREARM ARTERIOVENOUS FISTULA (CEPHALIC VEIN). A 5.0 X 40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND ANOTHER BALLOON OF THE SAME SIZE AND TYPE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16661198 ↗
• MalfunctionSep 1, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARM VESSEL. A 5.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, WHEN THE BALLOON WAS BEING INFLATED, THE BALLOON MATERIAL WAS NOTED TO BE LEAKING GAS. 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 15335986 ↗
• MalfunctionSep 28, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VASCULAR STENOSIS AT A STOMA SITE. A 5.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS SELECTED FOR DILATION. HOWEVER, AFTER SEVERAL INFLATIONS AT LESS WORKING PRESSURE FOR FEW SECOND, THE BALLOON RUPTURED. 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 12539036 ↗
• MalfunctionJun 8, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS INTERNAL FISTULA IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 5.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING FIRST INFLATION, 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 11962487 ↗
• MalfunctionFeb 26, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 5.0 X40, 40CM GLADIATOR BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, WHEN THE PHYSICIAN WAS FLUSHING THE BALLOON OUTSIDE THE PATIENT'S BODY, A PINHOLE WAS NOTICED ON THE BALLOON. THE BALLOON COULD NOT INFLATE 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 11384631 ↗
• MalfunctionDec 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN INTERNAL ARTERIOVENOUS FISTULA. A 5.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10999281 ↗
• InjuryOct 27, 2020Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED AND THE PATIENT DEVELOPED A HEMATOMA. THE TARGET LESION WAS LOCATED IN AN UPPER ARM VESSEL. A 5.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 6 ATMOSPHERES, IT WAS NOTICED THAT THE BALLOON WAS LEAKING FLUID. THE DEVICE WAS REMOVED AND TESTED FOR PRESSURE. IT WAS FOUND THAT THERE WAS A HOLE IN THE BALLOON. THE LONG OPERATION TIME RESULTED IN THE PATIENT DEVELOPING A HEMATOMA IN THE UPPER ARM. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL AND SENT TO SURGERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Hematoma

  MAUDE report 10744073 ↗
• MalfunctionAug 31, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.0 X40, 40CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10475024 ↗
• MalfunctionAug 11, 2020Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL FISTULA OF THE FOREARM. A 5.0 X40, 40CM GLADIATOR BALLOON CATHETER WAS ADVANCED. HOWEVER, DURING PROCEDURE THE CATHETER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10390830 ↗