UroMax Ultra KitRecalls & reported problems across all models
Boston Scientific Corporation · 14 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one UroMax Ultra Kit model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 14 models of UroMax Ultra Kit by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Jul 26, 2017 and Aug 18, 2026 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (7 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
UroMax Ultra Kit recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 5, 2025Open, Classified
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Z-2536-2025 · Root cause: Under Investigation by firm · names 12 of these models · Recall details · FDA record ↗
Most reported UroMax Ultra Kit problems
Device problems
- Burst Container or Vessel7
- Device Contamination with Chemical or Other Material6
- Material Puncture/Hole5
- Leak/Splash4
- Material Rupture4
- Material Deformation3
- Inflation Problem2
- Unsealed Device Packaging2
Patient problems
- No Clinical Signs, Symptoms or Conditions17
- No Consequences Or Impact To Patient9
- No Known Impact Or Consequence To Patient2
UroMax Ultra Kit models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- UroMax Ultra Kit M0062251210DILATOR, URETHRAL1 recall6 reports
- UroMax Ultra Kit M0062251220DILATOR, URETHRAL1 recall5 reports
- UroMax Ultra Kit M0062251370DILATOR, URETHRAL1 recall4 reports
- UroMax Ultra Kit M0062251200DILATOR, URETHRAL1 recall3 reports
- UroMax Ultra Kit M0062251290DILATOR, URETHRAL1 recall2 reports
- UroMax Ultra Kit M0062251310DILATOR, URETHRAL1 recall2 reports
- UroMax Ultra Kit M0062251240DILATOR, URETHRAL1 recall1 report
- UroMax Ultra Kit M0062251360DILATOR, URETHRAL1 recall0 reports
- UroMax Ultra Kit M0062251230DILATOR, URETHRAL1 recall0 reports
- UroMax Ultra Kit M0062251260DILATOR, URETHRAL1 recall0 reports
- UroMax Ultra Kit M0062251300DILATOR, URETHRAL1 recall0 reports
- UroMax Ultra Kit M0062251350DILATOR, URETHRAL1 recall0 reports
- UroMax Ultra Kit M0062251270DILATOR, URETHRAL4 reports
- UroMax Ultra Kit M0062251280DILATOR, URETHRAL1 report
Recent UroMax Ultra Kit adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Inflation Problem; Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50310182 ↗MalfunctionJul 6, 2026Burst Container or Vessel
IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER WAS USED DURING A DILATION OF URETER PROCEDURE. DURING THE PROCEDURE, THE BALLOON BURST. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25725454 ↗MalfunctionDec 23, 2025Fluid/Blood Leak; Leak/Splash; Fluid/Blood Leak; Leak/Splash
IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A URETEROSCOPY (URS), STRICTURE DILATION PROCEDURE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE BALLOON WAS NOT INFLATING. REPORTEDLY, UPON REMOVAL IT WAS FOUND THAT CONTRAST SOLUTION WAS LEAKING OUT FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877655 ↗MalfunctionOct 31, 2025Material Rupture; Device Contamination with Chemical or Other Material; Material Rupture; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES WERE SET FOR USE IN A PROCEDURE. HOWEVER, FOREIGN BODIES WERE FOUND INSIDE THE ENCORE INFLATION DEVICES OF THE UROMAX ULTRA BALLOON KIT. ADDITIONALLY, THE UROMAX ULTRA BALLOON DEVICES WERE ALSO NOTED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE FOURTH OF FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES IN REFERENCE TO MEDWATCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23441968 ↗MalfunctionOct 31, 2025Material Rupture; Device Contamination with Chemical or Other Material; Material Rupture; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES WERE SET FOR USE IN A PROCEDURE. HOWEVER, FOREIGN BODIES WERE FOUND INSIDE THE ENCORE INFLATION DEVICES OF THE UROMAX ULTRA BALLOON KIT. ADDITIONALLY, THE UROMAX ULTRA BALLOON DEVICES WERE ALSO NOTED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE THIRD OF FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES IN REFERENCE TO MEDWATCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23441965 ↗MalfunctionOct 31, 2025Material Rupture; Device Contamination with Chemical or Other Material; Material Rupture; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES WERE SET FOR USE IN A PROCEDURE. HOWEVER, FOREIGN BODIES WERE FOUND INSIDE THE ENCORE INFLATION DEVICES OF THE UROMAX ULTRA BALLOON KIT. ADDITIONALLY, THE UROMAX ULTRA BALLOON DEVICES WERE ALSO NOTED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE FIRST OF FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES IN REFERENCE TO MEDWATCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23441964 ↗MalfunctionOct 31, 2025Material Rupture; Device Contamination with Chemical or Other Material; Material Rupture; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES WERE SET FOR USE IN A PROCEDURE. HOWEVER, FOREIGN BODIES WERE FOUND INSIDE THE ENCORE INFLATION DEVICES OF THE UROMAX ULTRA BALLOON KIT. ADDITIONALLY, THE UROMAX ULTRA BALLOON DEVICES WERE ALSO NOTED TO BE RUPTURED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE SECOND OF FOUR UROMAX ULTRA BALLOON DILATATION CATHETER DEVICES IN REFERENCE TO MEDWATCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23441960 ↗MalfunctionOct 16, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT A UROMAX ULTRA DILATION BALLOON CATHETER WAS ABOUT TO BE USED DURING A URETERAL STRICTURE PROCEDURE. REPORTEDLY, THE BALLOON BURST DURING UNPACKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23318476 ↗MalfunctionOct 15, 2024Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A URETEROSCOPY AND BALLOON BURST. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20456300 ↗MalfunctionNov 20, 2023Unsealed Device Packaging; Device Contaminated During Manufacture or Shipping; Unsealed Device Packaging; Device Contaminated During Manufacture or Shipping
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS ABOUT TO BE USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, UPON OPENING OF THE PACKAGE IT WAS FOUND THAT THE ANCHOR INFLATOR STERILIZATION WAS OPEN AND NOT CLEAN. THE PROCEDURE WAS STILL COMPLETED WITH ANOTHER UROMAX ULTRA DILATION BALLOON CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18177632 ↗MalfunctionAug 22, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED IN THE URETER DURING A TRANSURETHRAL URETEROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE PRESSURE COULD NOT REACH, AND THE BALLOON WAS LEAKING LIQUID. 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 STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17599139 ↗MalfunctionMay 2, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA BALLOON WAS USED IN THE URETER DURING A TRANSURETHRAL URETEROLITHOTOMY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS LEAKING. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16855077 ↗MalfunctionFeb 3, 2023Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A NUROMAX ULTRA KIT WITH ENCORE 26 INFLATOR WAS USED IN THE KIDNEY DURING A LITHOTRIPSY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PROTECTIVE SLEEVE OF THE BALLOON WAS DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER NUROMAX ULTRA DILATION BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF SHAFT KINKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16292662 ↗MalfunctionMay 4, 2022Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATATION BALLOON CATHETER WAS USED IN THE LOWER URINARY TRACT DURING A TRANSURETHRAL LITHOTRIPSY (TUL) PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE BALLOON RUPTURED WHEN FUNCTIONAL CHECKING WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATATION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14274690 ↗MalfunctionFeb 28, 2022Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATION BALLOON CATHETER WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. 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 13618399 ↗
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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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