UroMax Ultra M0062251160Recalls & reported problems
Boston Scientific Corporation · Balloon Dilatation Catheter · Class 2
All models of UroMax Ultra (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729341246), received between Jul 26, 2021 and Nov 8, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Burst Container or Vessel1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 8, 2023Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A UROMAX ULTRA DILATION BALLOON CATHETER DEVICE WAS USED DURING A URETERAL DILATION PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE BALLOON RUPTURED EVEN THOUGH IT WAS INFLATED TO 12 ATMOSPHERIC PRESSURES (ATM) ONLY. THE PROCEDURE WAS 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 18096718 ↗MalfunctionJul 26, 2021Material Deformation; Material Deformation
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CATHETER WAS USED DURING AN URETEROSCOPY PROCEDURE PERFORMED ON(B)(6), 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN OPENED THE PACKAGE THE BALLOON WAS NOTED TO HAVE A SIGNIFICANT BEND. THE PROCEDURE WAS COMPLETED WITH ANOTHER UROMAX ULTRA DILATATION BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ***ADDITIONAL INFORMATION RECEIVED ON (B)(6)2021*** IT WAS REPORTED THAT THE UROMAX ULTRA DILATATION BALLOON CATHETER WAS USED IN THE URETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12224835 ↗
Other DILATOR, URETHRAL devices
- Bard® Urologist's Tray 123400C. R. Bard, Inc. · DILATOR, URETHRAL1 recall8 reports
- UroMax Ultra Kit M0062251210Boston Scientific Corporation · DILATOR, URETHRAL1 recall6 reports
- UroMax Ultra Kit M0062251220Boston Scientific Corporation · DILATOR, URETHRAL1 recall5 reports
- UroMax Ultra Kit M0062251370Boston Scientific Corporation · DILATOR, URETHRAL1 recall4 reports
- UroMax Ultra Kit M0062251200Boston Scientific Corporation · DILATOR, URETHRAL1 recall3 reports
- UroMax Ultra Kit M0062251290Boston Scientific Corporation · DILATOR, URETHRAL1 recall2 reports
- UroMax Ultra Kit M0062251310Boston Scientific Corporation · DILATOR, URETHRAL1 recall2 reports
- UroMax Ultra Kit M0062251240Boston Scientific Corporation · DILATOR, URETHRAL1 recall1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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