UroMax UltraRecalls & reported problems across all models
Boston Scientific Corporation · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 55
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 11 models of UroMax Ultra by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 55 adverse event reports in the FDA's MAUDE database, received between Jun 1, 2017 and Aug 20, 2026 — classified as 55 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (18 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 UroMax Ultra problems
Device problems
- Material Puncture/Hole18
- Burst Container or Vessel14
- Leak/Splash12
- Material Deformation8
- Inflation Problem4
- Break2
- Material Split, Cut or Torn2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions37
- No Consequences Or Impact To Patient15
- No Known Impact Or Consequence To Patient3
- Insufficient Information1
UroMax Ultra models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- UroMax Ultra M0062251020DILATOR, CATHETER, URETERAL11 reports
- UroMax Ultra M0062251080DILATOR, URETHRAL11 reports
- UroMax Ultra M0062251010DILATOR, URETHRAL9 reports
- UroMax Ultra M0062251000DILATOR, CATHETER, URETERAL7 reports
- UroMax Ultra M0062251070DILATOR, URETHRAL5 reports
- UroMax Ultra M0062251170DILATOR, CATHETER, URETERAL5 reports
- UroMax Ultra M0062251040DILATOR, URETHRAL2 reports
- UroMax Ultra M0062251160DILATOR, URETHRAL2 reports
- UroMax Ultra M0062251050DILATOR, URETHRAL1 report
- UroMax Ultra M0062251150DILATOR, URETHRAL1 report
- UroMax Ultra M0062251180DILATOR, URETHRAL1 report
Recent UroMax Ultra adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2026Fluid/Blood Leak
It was reported that a Uromax Ultra Dilation Balloon Catheter was used during a Ureteroscopy (URS) procedure. During the procedure, it was found that the coil of the tail was broken. Additionally, when the balloon was being inflated, a leak was discovered that prevented it from fully expanding. The procedure was completed with another of the same device with no patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50335394 ↗MalfunctionAug 10, 2026Break; Inflation Problem; Nonstandard Device
It was reported that a Uromax Ultra Dilation Balloon Catheter was used during a Ureterorenolithotripsy (URSL) procedure. During the procedure, it was found that the coil of the tail was broken and the balloon could not be inflated. The procedure was completed with another of the same device with no patient complications.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50196975 ↗MalfunctionApr 10, 2026Failure to Deflate
IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED IN A PROCEDURE. REPORTEDLY, THE BALLOON DEVICE WAS INFLATED AS INTENDED; HOWEVER, IT DID NOT DEFLATE. THE DEVICE WAS WITHDRAWN WHILE STILL IN AN EXPANDED STATE WITHIN THE URETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24839696 ↗MalfunctionNov 5, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT A UROMAX ULTRA BALLOON DILATION CATHETER DEVICE WAS SET FOR USE IN A TRANSURETHRAL URETEROSCOPIC HOLMIUM LASER LITHOTRIPSY PROCEDURE. DURING PREPARATION, IT WAS NOTICED THAT THE BALLOON HAD A SMALL HOLE AND WAS LEAKING WATER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED THAT A BALLOON PINHOLE LEAK WAS NOTED APPROXIMATELY 12MM PROXIMAL FROM THE DISTAL MARKERBAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23475972 ↗MalfunctionJun 30, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. REPORTEDLY, THE UROMAX BALLOON BROKE DURING INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22365294 ↗MalfunctionMay 27, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole
IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A TRANSURETHRAL URETEROSCOPIC LASER LITHOTRIPSY PROCEDURE. DURING THE PROCEDURE IT WAS NOTICED THAT IT HAD A SMALL HOLE ON THE CATHETER, AND THE WATER FLOWED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED THAT A BALLOON PINHOLE LEAK WAS NOTED 18MM DISTAL FROM THE PROXIMAL MARKERBAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22091804 ↗MalfunctionFeb 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT AUROMAX ULTRA DILATION BALLOON CATHETER WAS ABOUT TO BE USED DURING A RETROGRADE INTRARENAL SURGERY (RIRS). DURING PREPARATION, IT WAS FOUND THAT THE BALLOON WAS TORN AS SOON AS THEY REMOVED THE PACKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356529 ↗MalfunctionJan 8, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn
IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE. DURING THE PROCEDURE, THE BALLOON WAS PRE-INFLATED BEFORE THE INSERTION; HOWEVER, THE BALLOON WAS TORN AND DEFLATED IMMEDIATELY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21106939 ↗MalfunctionJan 8, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS ABOUT TO BE USED DURING A URETEROSCOPY PROCEDURE. REPORTEDLY, UPON OPENING THE UROMAX BALLOON A HAIR WAS FOUND WITHIN THE STERILE PACKAGE. ADDITIONALLY, THERE WAS NO DAMAGE FOUND ON THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21106900 ↗MalfunctionOct 29, 2024Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole
IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A URETEROSCOPIC LITHOTRIPSY (URSL) PROCEDURE. REPORTEDLY, THE BALLOON COULD NOT DILATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED BASKET IDENTIFIED THAT A PINHOLE IN THE BALLOON MATERIAL WAS FOUND LOCATED APPROXIMATELY 2MM DISTAL OF THE DISTAL MARKERBAND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20563701 ↗MalfunctionSep 4, 2024Material Deformation; Material Deformation
IT WAS REPORTED THAT DURING PREPARATION A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS FOUND BENT AT THE END OF THE BALLOON WHERE IT WAS ROLLED UP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20141069 ↗MalfunctionMay 3, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. DURING THE PROCEDURE, THE CONTRAST MEDIA WAS LEAKED FROM THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A PINHOLE IN THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19243678 ↗MalfunctionApr 22, 2024Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole
IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE. DURING THE PROCEDURE THE BALLOON WAS INSERTED AND ATTEMPTED TO INFLATE; HOWEVER, THE BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON PINHOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19160673 ↗MalfunctionMar 11, 2024Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE CATHETER SHOWS BENDING DAMAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATION BALLOON CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18882208 ↗MalfunctionFeb 20, 2024Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS TO BE USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE BALLOON EXPANSION DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATION BALLOON CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF BALLOON PINHOLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18741415 ↗
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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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