Gladiator™ Elite H74939207040870Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729809630), received between Feb 20, 2023 and Feb 20, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2023Break; Difficult to Remove; Material Rupture; Break; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE, REMOVAL DIFFICULTY AND SHAFT BREAK OCCURRED. THE 60-70% STENOSED TARGET LESION WAS LOCATED IN A VESSEL OF THE ARM. A 4.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE SECOND INFLATION AT 18 ATMOSPHERES FOR 25 SECONDS, THE BALLOON BURST INSIDE THE PATIENT AND COULD NOT BE WITHDRAWN. THE BALLOON WAS STUCK IN THE SHEATH OPENING AND WAS LATER WITHDRAWN TOGETHER WITH THE RADIAL SHEATH. IT WAS ALSO NOTED THAT OUTSIDE OF THE PATIENT, THE BALLOON WAS FRACTURED ABOUT A MILLIMETER FROM THE TIP. 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 16406121 ↗