UroMax Ultra Kit M0062251290Recalls & reported problems
Boston Scientific Corporation · Balloon Dilatation Catheter Kit · Class 2
All models of UroMax Ultra Kit (14)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729341369), received between Oct 16, 2025 and Jul 6, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).
1 FDA recall record name this device's 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, 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
Recalls naming this device
- Aug 5, 2025Class IIOpen, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Burst Container or Vessel2
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.
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 ↗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 ↗
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 M0062251310Boston Scientific Corporation · DILATOR, URETHRAL1 recall2 reports
- UroMax Ultra Kit M0062251240Boston Scientific Corporation · DILATOR, URETHRAL1 recall1 report
- UroMax Ultra Kit M0062251300Boston Scientific Corporation · DILATOR, URETHRAL1 recall0 reports
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 · each recall links to the FDA recall notice
- 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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