Gladiator™ Elite H74939207070670Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729809814), received between Feb 12, 2019 and Sep 25, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 7.0 X60, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING INFLATION WITHOUT BEING REACH TO THE MAXIMUM PRESSURE, THE BALLOON BURST. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 20 ATMOSPHERES. THE DEVICE WAS REMOVED INTACT OVER THE WIRE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17813326 ↗
• MalfunctionApr 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A THROMBOSED VEIN GRAFT. A 7.0 X60, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, ON THE FIRST INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS PULLED AND REMOVED THROUGH THE SHEATH. ANOTHER 7X60 GLADIATOR ELITE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16661114 ↗
• MalfunctionOct 18, 2022Break; Deflation Problem; Difficult to Remove; Break; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DEFLATION SLOW AND DIFFICULTY REMOVAL OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED ARM SHUNT. A 7.0 X60, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION AND INFLATED AT 5-8 ATMOSPHERES FOR 2 MINUTES BUT THE BALLOON WAS NOT ABLE TO DEFLATE COMPLETELY. BALLOONS FLUID MIX WAS COMPLETELY ASPIRATED, HOWEVER, THE PHYSICIAN STATED THAT THE BALLOON RETAINED AIR AND THE AIR BUMBLING THE BALLOON PREVENTED IT FROM DEFLATING AND THEREFORE HAD TO BE PULLED OUT WITH GREAT DIFFICULTY AFTER ALL ATTEMPTS TO REMOVE THE RESIDUAL AIR IN THE BALLOON WAS ATTEMPTED. THE BALLOON WAS FINALLY REMOVED WITH FORCE AND A GLADIATOR ELITE 7X40X75 WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624746 ↗
• MalfunctionDec 18, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 7.0 X60, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION, UNDER WORKING PRESSURE, THE BALLOON RUPTURED. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11037517 ↗
• MalfunctionApr 2, 2019Material 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 THE CEPHALIC VEIN. A 7.0X60, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR INTRA-STENT DILATATION. HOWEVER, DURING THIRD INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8476137 ↗
• MalfunctionFeb 12, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. THE TARGET LESION WAS LOCATED IN THE VEIN GRAFT ANASTAMOSIS. A 7.0 X60, 75CM BALLOON CATHETER WS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8332095 ↗