Ultraxx G46038Recalls & reported problems
Cook Incorporated · Ultraxx Nephrostomy Balloon Set Clear Amplatz Sheath With Radiopaque Stripe · Class U
All models of Ultraxx (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002460386), received between Feb 16, 2017 and Feb 16, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Renal Failure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 16, 2017Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE VIA ACCESS FROM THE KIDNEY. AN ULTRAXX NEPHROSTOMY BALLOON SET WAS USED. THE ATTENDING PHYSICIAN INDICATED THE BALLOON WAS INFLATED AND FOUND LEAKING AT 13 TO 14 PSI. THE PHYSICIAN STATED THAT SOME RESISTANCE WAS MET DURING INFLATION OF THE BALLOON. THE RENAL HILUM BLOOD VESSELS WERE BLEEDING DUE TO THE EXPANSION LOCATION WAS RELATIVELY DEEPER. THE PHYSICIAN ATTEMPTED TO CHANGE THE PUNCTURE CHANNEL BUT WAS UNSUCCESSFUL CAUSING THE REMOVAL OF THE RIGHT KIDNEY. THE RENAL REPAIR WAS FUTILE HOWEVER; THE PHYSICIAN HAD TO USE A BARD BALLOON INSTEAD TO COUNTERACT THE LOSS OF THAT FUNCTION. NO FURTHER INFORMATION PROVIDED.
Patient problems: Renal Failure
MAUDE report 6336462 ↗
Other CATHETER, NEPHROSTOMY devices
- Cook G09501Cook Incorporated · CATHETER, NEPHROSTOMY280 reports
- Dawson Mueller G09705Cook Incorporated · CATHETER, NEPHROSTOMY2 deaths215 reports
- Cook G09497Cook Incorporated · CATHETER, NEPHROSTOMY129 reports
- Dawson Mueller G11020Cook Incorporated · CATHETER, NEPHROSTOMY100 reports
- Cook G09502Cook Incorporated · CATHETER, NEPHROSTOMY86 reports
- NephroMax Kit M0062101180Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall25 reports
- NephroMax Kit M0062101600Boston Scientific Corporation · CATHETER, NEPHROSTOMY1 recall11 reports
- Dawson Mueller G13768Cook Incorporated · CATHETER, NEPHROSTOMY59 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
- 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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