Ultraxx G30365Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002303652), received between Apr 17, 2018 and Apr 15, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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, 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19112842 ↗
• MalfunctionMar 31, 2022Material Rupture; Material Twisted/Bent; Material Rupture; Material Twisted/Bent

  AS REPORTED, AN ULTRAXX NEPHROSTOMY BALLOON AND SET RUPTURED AT AN UNKNOWN PRESSURE. THE DEVICE WAS USED FOR ACCESS DURING A PERCUTANEOUS NEPHROLITHOTOMY. THE BALLOON WAS "EXTREMELY DIFFICULT" TO INFLATE AND THE KNOB WAS HARD TO TURN. AFTER THE RUPTURE, THE SHEATH WAS PLACED OVER THE BALLOON AND BENT IN TWO PLACES (IT IS UNKNOWN WHICH DEVICE BENT). A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13971384 ↗
• MalfunctionNov 15, 2019Material Separation; Material Separation

  IT IS REPORTED DURING THE REMOVAL OF A LEFT STAGHORN CALCULUS IN AN ADULT MALE PATIENT USING A ULTRAXX NEPHROSTOMY BALLOON AND SET, WHEN ATTEMPTING TO DILATE A RETRACTOR, THE BALLOON BROKE INSIDE THE PATIENT AND THE FLUID DRAINED OUT. THE ISSUE OCCURRED DURING THE BALLOON INFLATION. THE BALLOON WAS WITHDRAWN AND A SECOND BALLOON WAS USED WITHOUT COMPLICATION TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9329633 ↗
• MalfunctionJun 12, 2019Material Rupture; Material Rupture

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8692144 ↗
• MalfunctionApr 17, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED AN ULTRAXX NEPHROSTOMY BALLOON SET WAS DILATED IN A PCNL TO ESTABLISH A NEPHROSTOMY TRACT INTO THE KIDNEY FOR STONE MANIPULATION, HOWEVER, THE SHEATH WOULD NOT ADVANCE. A SECOND ATTEMPT WAS MADE AT AN ALTERNATIVE PUNCTURE SITE WHERE THE SHEATH WOULD NOT ADVANCE AGAIN. THE PHYSICIAN STATED THERE WAS SIGNIFICANT SPACE BETWEEN THE OUTER DIAMETER OF THE BALLOON AND THE INNER DIAMETER OF THE SHEATH DESPITE COMPLETE INFLATION OF THE BALLOON. THE CASE WAS ABORTED AND THE PATIENT¿S STONES REMAIN WITHIN THE KIDNEY. THE PHYSICIAN HAS REFERRED THE PATIENT TO ANOTHER FACILITY FOR A PROBABLE PCNL AS FURTHER TREATMENT. TO DATE, NO KNOWN ADVERSE CONSEQUENCES TO THE PATIENT RESULTED FROM THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 7438557 ↗