Gladiator EliteRecalls & reported problems across all models
Boston Scientific Corporation · 27 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 503
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls
- 0
We found 27 models of Gladiator Elite by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 503 adverse event reports in the FDA's MAUDE database, received between Aug 31, 2018 and Aug 18, 2026 — classified as 26 injuries, 477 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (424 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Gladiator Elite problems
Device problems
- Material Rupture424
- Adverse Event Without Identified Device or Use Problem41
- Leak/Splash37
- Inflation Problem33
- Difficult to Remove17
- Material Integrity Problem16
- Break15
- Fluid/Blood Leak11
Patient problems
- No Clinical Signs, Symptoms or Conditions347
- No Consequences Or Impact To Patient141
- No Patient Involvement6
- Hematoma4
- No Known Impact Or Consequence To Patient4
- No Code Available3
- Discomfort1
- Embolism/Embolus1
Gladiator Elite models
27 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Gladiator™ Elite H74939207060470Catheter, angioplasty, peripheral, transluminal71 reports
- Gladiator™ Elite H74939207120470Catheter, angioplasty, peripheral, transluminal69 reports
- Gladiator™ Elite H74939207100470Catheter, angioplasty, peripheral, transluminal56 reports
- Gladiator™ Elite H74939207060440Catheter, angioplasty, peripheral, transluminal52 reports
- Gladiator™ Elite H74939207070870Catheter, angioplasty, peripheral, transluminal40 reports
- Gladiator™ Elite H74939207050470Catheter, angioplasty, peripheral, transluminal33 reports
- Gladiator™ Elite H74939207070470Catheter, angioplasty, peripheral, transluminal27 reports
- Gladiator™ Elite H74939207080470Catheter, angioplasty, peripheral, transluminal26 reports
- Gladiator™ Elite H74939207070440Catheter, angioplasty, peripheral, transluminal20 reports
- Gladiator™ Elite H74939207040470Catheter, angioplasty, peripheral, transluminal17 reports
- Gladiator™ Elite H74939207080870Catheter, angioplasty, peripheral, transluminal17 reports
- Gladiator™ Elite H74939207050440Catheter, angioplasty, peripheral, transluminal15 reports
- Gladiator™ Elite H74939207060870Catheter, angioplasty, peripheral, transluminal14 reports
- Gladiator™ Elite H74939207100870Catheter, angioplasty, peripheral, transluminal14 reports
- Gladiator™ Elite H74939207040440Catheter, angioplasty, peripheral, transluminal7 reports
- Gladiator™ Elite H74939207070670Catheter, angioplasty, peripheral, transluminal6 reports
- Gladiator™ Elite H74939207060840Catheter, angioplasty, peripheral, transluminal4 reports
- Gladiator™ Elite H74939207080670Catheter, angioplasty, peripheral, transluminal3 reports
- Gladiator™ Elite H74939207090470Catheter, angioplasty, peripheral, transluminal3 reports
- Gladiator™ Elite H74939207070270Catheter, angioplasty, peripheral, transluminal2 reports
- Gladiator™ Elite H74939207030440Catheter, angioplasty, peripheral, transluminal1 report
- Gladiator™ Elite H74939207040870Catheter, angioplasty, peripheral, transluminal1 report
- Gladiator™ Elite H74939207050270Catheter, angioplasty, peripheral, transluminal1 report
- Gladiator™ Elite H74939207050870Catheter, angioplasty, peripheral, transluminal1 report
- Gladiator™ Elite H74939207060270Catheter, angioplasty, peripheral, transluminal1 report
- Gladiator™ Elite H74939207080440Catheter, angioplasty, peripheral, transluminal1 report
- Gladiator™ Elite H74939207090870Catheter, angioplasty, peripheral, transluminal1 report
Recent Gladiator Elite adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50295719 ↗MalfunctionAug 17, 2026Inflation Problem; Nonstandard Device; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50278483 ↗MalfunctionAug 14, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254252 ↗MalfunctionApr 9, 2026Fluid/Blood Leak
REPORTABLE BASED ON HE DEVICE ANALYSIS COMPLETED ON 19MAR2026. IT WAS REPORTED THAT CATHETER LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CEPHALIC VEIN. A 7.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INITIAL INFLATION, WHEN THE BALLOON WAS PRESSURIZED TO 18 ATMOSPHERES, LEAKAGE OF FLUID FROM THE BALLOON WAS OBSERVED, AND THE DEVICE COULD NOT MAINTAIN PRESSURE. THE INFLATION WAS IMMEDIATELY STOPPED, AND THE BALLOON CATHETER WAS WITHDRAWN FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER BALLOON CATHETER OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BALLOON PINHOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24825676 ↗MalfunctionApr 2, 2026Fluid/Blood Leak; Inflation Problem
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12MAR2026. IT WAS REPORTED THAT BALLOON WAS UNABLE TO INFLATE. THE 53% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED BASILIC VEIN. A 6.0 X80, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE INITIAL PRESSURIZATION TO 8 ATMOSPHERES, THE BALLOON COULD NOT MAINTAIN THE PRESSURE. THE BALLOON WAS WITHDRAWN FROM THE BODY, AND IT WAS FOUND THAT THE BALLOON WAS LEAKING LIQUID. NO PINHOLE WAS NOTED ON THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A LONGITUDINAL TEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24763910 ↗MalfunctionMar 26, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CEPHALIC VEIN. A 4.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 26 ATMOSPHERES FOR 15 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THIS EVENT RESULTED IN PROLONGED OPERATION TIME AND INCREASED PATIENT DISCOMFORT.
Patient problems: Discomfort
MAUDE report 24700153 ↗MalfunctionMar 22, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE FOREARM VESSEL. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 22 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24658984 ↗MalfunctionMar 19, 2026Material Rupture; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 58% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUBCLAVIAN ARTERY. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE FIRST PRESSURE EXPANSION OF THE LESION, A PRESSURE OF 16 ATMOSPHERES WAS APPLIED AND THE BALLOON EXPANDED NORMALLY WHILE MAINTAINING THE PRESSURE. DURING THE SECOND EXPANSION OF THE LESION, A PRESSURE OF 10 ATMOSPHERES WAS APPLIED BUT THE BALLOON FAILED TO MAINTAIN THE PRESSURE. IMMEDIATELY, THE PRESSURE WAS RELEASED, AND THE BALLOON WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24641784 ↗MalfunctionMar 17, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. A 6.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AT 22 ATMOSPHERES. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615416 ↗InjuryMar 10, 2026Difficult to Remove; Material Rupture
IT WAS REPORTED THAT BALLOON BURST AND ADDITIONAL INTERVENTION WAS PERFORMED. THE PATIENT PRESENTED WITH POOR DIALYSIS BLOOD FLOW FOR APPROXIMATELY ONE MONTH. EXAMINATION IDENTIFIED VASCULAR STENOSIS OF THE ARTERIOVENOUS FISTULA AS THE CAUSE. TO IMPROVE DIALYSIS FLOW, AN 8 MM GLADIATOR BALLOON DILATATION CATHETER WAS SELECTED. SEVERAL DILATIONS WERE PERFORMED BEGINNING AT THE PROXIMAL STENOTIC REGION OF THE CEPHALIC VEIN USING 8 TO 20 ATMOSPHERES FOR APPROXIMATELY 60 SECONDS PER INFLATION. DURING DILATION OF THE FISTULA OPENING, APPROXIMATELY 20 ATMOSPHERES WAS APPLIED FOR ABOUT 40 SECONDS WHEN THE BALLOON SUDDENLY BURST. IMMEDIATE EXAMINATION CONFIRMED NO VESSEL RUPTURE OR ACTIVE BLEEDING. HOWEVER, THE BALLOON WAS DIFFICULT TO WITHDRAW AND WAS REPORTED TO HAVE COLLAPSED. HEMOSTASIS WAS ACHIEVED USING A TOURNIQUET. THE PUNCTURE SITE AND VESSEL WERE SURGICALLY OPENED TO REMOVE THE BALLOON, AND THE VESSEL WAS SUTURED. AFTER TOURNIQUET RELEASE, NO BLEEDING OR OOZING WAS OBSERVED. THE SKIN WAS SUBSEQUENTLY SUTURED, DISINFECTED WITH IODOPHOR, AND BANDAGED. THERE WERE NO FURTHER PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24561505 ↗MalfunctionMar 3, 2026Material Rupture
IT WAS REPORTED THAT BALLOON BURST OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL IN THE LOWER ARM. A 10.0 X 40, 75 CM GLADIATOR ELITE BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE FIRST INFLATION AT 14 ATMOSPHERES, THE DEVICE DID NOT HOLD PRESSURE AND RUPTURED IMMEDIATELY. THE DEVICE WAS REMOVED SUCCESSFULLY FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24503120 ↗MalfunctionFeb 16, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X40, 75CM GLADIATOR? ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER THE FIRST INFLATION AT 8 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24349878 ↗MalfunctionFeb 6, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS FISTULA. A 5.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24283563 ↗MalfunctionFeb 4, 2026Material Rupture
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A VERY FIBROTIC ARTERIOVENOUS FISTULA. A 10.0 X40, 75CM GLADIATOR ELITE BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE INFLATION, THE BALLOON RUPTURED WITHOUT REACHING THE RATED BURST PRESSURE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24262117 ↗MalfunctionJan 30, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0 X40, 75CM GLADIATOR? ELITE BALLOON WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED DURING IN-STENT INFLATION AFTER THE FIRST INFLATION AT 14 ATMOSPHERES. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE USED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24228361 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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