Gladiator™ Elite H74939207040440Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729809609), received between Jun 9, 2020 and Aug 12, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED INTERNAL ARTERIOVENOUS FISTULA. A 4.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIFTH TO SIXTH INFLATION AT 20 ATMOSPHERES FOR 50 TO 60 SECONDS. THE DEVICE WAS REMOVED, AND 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 19960210 ↗
• MalfunctionJun 18, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT'S INTERNAL FISTULA FUNCTION WAS POOR, AND ADEQUATE DIALYSIS WAS NOT POSSIBLE. INTERNAL FISTULA STENOSIS OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED LEFT FOREARM. A 4.0 X40, 40CM GLADIATOR ELITE WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, ON THE FIRST INFLATION AT 14 ATMOSPHERES AT 5 SECONDS BY PUMP, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19556948 ↗
• MalfunctionAug 29, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ARTERIOVENOUS FISTULA. A 4.0 X40, 40CM GLADIATOR ELITE 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 THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640608 ↗
• MalfunctionDec 13, 2022Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN INTERNAL ARTERIOVENOUS FISTULA. A 4.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS BROKEN. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT CONDITION WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 60-70% STENOSED WITH A SIGNIFICANT BEND OF >90 DEGREES, MILDLY TORTUOUS, AND SEVERELY CALCIFIED. ADDITIONALLY, BALLOON RUPTURE OCCURRED INSTEAD OF THE PREVIOUSLY REPORTED SHAFT BREAK AS PINHOLE WAS NOTED ON THE BALLOON MATERIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15971599 ↗
• MalfunctionOct 19, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 4.0 X40, 40CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION, 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 12656889 ↗
• MalfunctionJul 23, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT HAD POOR FLOW DURING DIALYSIS. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RADIAL ARTERY. A 4.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. THE BALLOON WAS INFLATED SEVERAL TIMES; HOWEVER, DURING INFLATION AT LESS WORKING PRESSURE FOR 10-30 SECONDS, THE CONTRAST AGENT PUMPED BACK AND THE LIQUID IN THE PUMP COULD BE SEEN RED. THE DEVICE WAS SIMPLY REMOVED, AND FOUND 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 12216392 ↗
• MalfunctionJun 9, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED ABOVE THE ANSTOMOTIC STOMA. A 4.0 X40, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE PHYSICIAN REMOVED THE BALLOON IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10132743 ↗