Gladiator™ Elite H74939207060840Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729809746), received between Feb 20, 2023 and Jul 31, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025Material 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 80% - 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS ARTERIOVENOUS FISTULA. A 6.0 X80, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURE AFTER THE SIXTH TO SEVENTH INFLATION AT 20 ATMOSPHERES FOR 40 TO 50SECONDS. THE PROCEDURE WAS COMPLETED USING 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 22679873 ↗
• MalfunctionApr 16, 2023Material 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 LOCATED IN ARTERIOVENOUS FISTULA. A 6.0 X80, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCE FOR DILATATION. HOWEVER, DURING PROCEDURE, THE BALLOON WAS BROKEN. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATION NOR INJURIES REPORTED AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED WITH 70%-80 STENOSIS. THE BALLOON RUPTURED DURING INFLATION AT 20 ATMOSPHERES FOR 40 SECONDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748625 ↗
• MalfunctionApr 12, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ARTERIOVENOUS FISTULA. A 6.0 X80, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOON BURST OUT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT CONDITION WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 80-90% STENOSED, MODERATELY TORTUOUS AND SEVERELY CALCIFIED. THE BALLOON RUPTURED ON THE FIFTH INFLATION AT 20 ATMOSPHERES FOR 40 TO 50 SECONDS. THE DEVICE WAS REMOVED WITH CATHETER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724325 ↗
• MalfunctionFeb 20, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 6.0 X80, 40CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE BALLOON WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS SEVERELY TORTUOUS AND MODERATELY CALCIFIED WITH 80-90% STENOSIS. THE BALLOON RUPTURED DURING SIXTH INFLATION AT 30 ATMOSPHERES FOR 50 SECONDS AND WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404220 ↗