Ultraxx G46033Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002460331), received between Mar 20, 2020 and Jul 11, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2022Leak/Splash; Leak/Splash

  AS REPORTED, DURING A MINI PERCUTANEOUS NEPHROLITHOTOMY, WATER LEAKED FROM THE BALLOON BODY ON AN ULTRAXX NEPHROSTOMY BALLOON. THE LEAK WAS NOTED PRIOR TO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED WITH A NEW SAME TYPE DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14977361 ↗
• MalfunctionApr 25, 2022Material Rupture; Material Rupture

  AS REPORTED, DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL), A ULTRAXX NEPHROSTOMY BALLOON WAS INFLATED WITH WATER TO 15 ATMOSPHERES AND LEAKED FROM THE BODY OF THE BALLOON. THE DEVICE DID NOT MAKE PATIENT CONTACT. A NEW SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14192528 ↗
• MalfunctionApr 5, 2022Material Rupture; Material Rupture

  AS REPORTED, PRIOR TO A PERCUTANEOUS NEPHROLITHOTOMY, A ULTRAXX NEPHROSTOMY BALLOON LEAKED WATER FROM THE BALLOON BODY UPON INFLATION TO 15 ATMOSPHERES. A NEW SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENTS BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THE OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014939 ↗
• MalfunctionMar 7, 2021Material Rupture; Material Rupture

  AS REPORTED, DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) AND USING A ULTRAXX NEPHROSTOMY BALLOON, LEAKAGE FROM THE BALLOON BODY OCCURRED. THE PHYSICIAN WAS INFLATING THE DEVICE WITH WATER, AND AROUND 15ATM THE DEVICE BEGAN TO LEAK. THIS OCCURRED PRIOR TO USE ON THE PATIENT. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE COMPLAINANT HAS NOT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11430118 ↗
• MalfunctionOct 29, 2020Material 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 10754343 ↗
• MalfunctionMar 20, 2020Fluid/Blood Leak; Fluid/Blood Leak

  NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9859338 ↗