Gladiator™ Elite H74939207090470Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729809951), received between Mar 18, 2019 and Feb 8, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2024Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT THE BALLOON POPPED. THE STENOSED TARGET LESION WAS LOCATED IN THE VESSEL OF THE ARM. A 9.0 X40, 75CM GLADIATOR ELITE BALLOON WAS SELECTED FOR USE IN A PROCEDURE. HOWEVER, IT WAS NOTED THAT THE BALLOON POPPED, AND THEY COULD NOT BRING IT BACK INTO THE SHEATH. THE SHEATH AND THE BALLOON HAD TO BE REMOVED AS ONE AND THE PROCEDURE WAS COMPLETED BY HOLDING THE PRESSURE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN GOOD CONDITION POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667733 ↗
• MalfunctionSep 13, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED VESSEL OF THE LEFT ARM. A 9.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE INITIAL INFLATION, THE BALLOON WOULD NOT INFLATE TO ITS MAXIMUM INFLATION PRESSURE AND IT RUPTURED. THE BALLOON STARTED TO LOSE PRESSURE AT AROUND 10 ATMOSPHERES. A VISIBLE PINHOLE WAS NOTED ON THE BALLOON. THE DEVICE WAS COMPLETELY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 9.0 X40 GLADIATOR BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15413655 ↗
• MalfunctionMar 18, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE LEFT ARM. A 9.0 X 40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATION AT 9 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8428130 ↗