Gladiator™ Elite H74939207070270Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729809777), received between Dec 21, 2022 and Feb 7, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE PATIENT PRESENTED WITH ARTIFICIAL ARTERIOVENOUS FISTULA STENOSIS AND UNDERWENT AUTOLOGOUS ARTERIOVENOUS ENDOVASCULAR BALLOON INFLATION AND ANGIOPLASTY. THE STENOSED TARGET LESION WAS LOCATED IN THE RADIAL ARTERY. A 7.0 X20, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT 20 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311143 ↗
• MalfunctionDec 21, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT SHAFT HOLE WAS ENCOUNTERED. A 7.0 X20, 75CM GLADIATOR ELITE BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, A HOLE WAS NOTICED IN THE SHAFT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030349 ↗