Gladiator™ Elite H74939207100870Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729826415), received between Oct 30, 2018 and Aug 8, 2024 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT BALLOON RUPTURE, DIFFICULTY TO REMOVE, BALLOON DETACHMENT, AND ADDITIONAL INTERVENTION OCCURRED. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED FISTULA. A 10.0 X80, 75CM GLADIATOR BALLOON CATHETER WAS SELECTED FOR TREATMENT. THE PRESSURE WAS BROUGHT UP 3 TIMES WITH THE PREVIOUS BEING 18-20 MMHG. DURING THIS PROCEDURE, ON THE THIRD INFLATION AT 20 ATMOSPHERES FOR 15 SECONDS, THE BALLOON RUPTURED. AN ATTEMPT WAS MADE TO REMOVE THE BALLOON, BUT ONLY THE PROXIMAL PORTION WAS ABLE TO BE WITHDRAWN THROUGH A 6FR 7CM SHEATH. THE DISTAL PART WAS PULLED TO THE ACCESS SITE WHERE AN INCISION WAS MADE SO A SURGICAL INTERVENTION WOULD BE PERFORMED BY MAKING A LARGE UPSIZING OF THE VENOTOMY TO GET THE BALLOON AND SHEATH OUT WITHOUT THE BALLOON FRACTURING. THERE WAS AN IN-ROOM CUT-DOWN AND WIDENING TO ENSURE CAPTURE OF EVERYTHING. THE REMAINDER OF THE BALLOON WAS WITHDRAWN BUT EVERTED UPON ITSELF. A 7FR 11CM SHEATH WAS USED TO TRY TO OBTAIN HEMOSTASIS BUT WAS UNSUCCESSFUL, THUS, A 10FR 11CM SHEATH WAS USED. PRESSURE WAS APPLIED TO THE FISTULA AT THE WRIST AND WAS SUTURED. PATIENT WAS DISCHARGED IN A STABLE CONDITION AND IS EXPECTED TO FULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19942648 ↗
• MalfunctionMay 13, 2022Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS FISTULA. A 035/180 STARTER GUIDEWIRE WAS USED TO CROSS THE LESION AND A 10.0 X80, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE WIRE SEEMED TO SHEAR AND THE BALLOON WAS STUCK ON ITSELF. THE BALLOON WAS NOT INFLATED AT THAT POINT, IT WAS JUST POSITIONED AND NOTICED IT WAS STUCK IN THE WIRE. THE BALLOON SHAFT WAS ALSO NOTED TO BE KINKED. BOTH THE BALLOON AND GUIDEWIRE WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14395669 ↗
• MalfunctionJun 15, 2021Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT BALLOON LEAK WERE ENCOUNTERED. THE PATIENT UNDERWENT LOWER EXTREMITY VEIN STENTING. A 10.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, IT WAS NOTED THAT THE BALLOON WAS LEAKING LIQUID. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12005795 ↗
• MalfunctionNov 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A FISTULA. A 10.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INFLATION AT NOMINAL PRESSURE, THE BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791308 ↗
• MalfunctionApr 22, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN ILIAC VEIN ARTERY. A 10.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR POST-DILATION. HOWEVER, DURING INFLATION, THE BALLOON WAS DAMAGED AND VISIBLE PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986083 ↗
• MalfunctionApr 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A FISTULA. TWO GLADIATOR ELITE BALLOON CATHETERS, A 12.0X40, 75CM AND A 10.0X80, 75CM, WERE USED CONSECUTIVELY FOR DILATATION. HOWEVER, DURING INFLATION, THE BALLOONS RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9949077 ↗
• MalfunctionFeb 10, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. A 10.0 X80, 75CM GLADIATOR BALLOON CATHETER WAS SELECTED FOR USE. THE BALLOON WAS TOOK OUT FROM THE PACKAGE FOR PREPARATION. HOWEVER, A PINHOLE WAS NOTED AS WHEN THE SOLUTION WAS PUT THROUGH THE DEVICE, IT ALL SPRAYED OUT. 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 9690351 ↗
• MalfunctionFeb 5, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN AN ARTERIOVENOUS FISTULA. A 10.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FO DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATION WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9673777 ↗
• MalfunctionJun 26, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 10.0 X 80, 75 CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS BROKEN BEFORE IT REACHED THE BURSTING PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8735698 ↗
• MalfunctionApr 8, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED GRAFT VENOUS ANASTOMOSIS. A 10.0 X 80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERES, A PIN HOLE LEAK WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492285 ↗
• MalfunctionMar 21, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC VEIN. A 10.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, UPON INFLATION AT 6 ATMOSPHERES FOR 10 SECONDS, THE BALLOON RUPTURED. NO SEGMENT OF THE BALLOON WAS DETACHED INSIDE THE PATIENT AFTER IT RUPTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8441853 ↗
• MalfunctionMar 4, 2019Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A VESSEL IN THE UPPER EXTREMITY. A 10.0 X80, 75CM GLADIATOR BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, UPON INFLATING TO BURST PRESSURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8387591 ↗
• MalfunctionFeb 4, 2019Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14 JAN 2019. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 10.0 X 80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, WHEN THE DEVICE WAS INSERTED INTO THE LESION, THE PRESSURE DID NOT CHANGED. IT WAS NOTED THAT THE BALLOON WAS LEAKING NEAR THE HANDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON PINHOLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8302475 ↗
• MalfunctionOct 30, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. A 10.0 X80, 75CM GLADIATOR BALLOON CATHETER WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE BALLOON SHEERED OFF. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8020816 ↗