Ultraxx G30357Recalls & 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
- 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 00827002303577), received between Mar 13, 2020 and May 5, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 5, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11777714 ↗MalfunctionMar 13, 2020Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED, DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) USING A ULTRAXX NEPHROSTOMY BALLOON AND SET, THE STOPCOCK WAS LETTING OUT PRESSURE AND FLUID. WHEN STARTING TO INFLATE THE BALLOON, THE STOPCOCK WAS LETTING OUT PRESSURE AND FLUIDS (1/2 CONTRAST AND 1/2 SALINE). THE STOPCOCK WAS LEAKING WHERE IT TIGHTENS TO THE CATHETER. THE BALLOON WAS INFLATED/DEFLATED TWO TIMES. THE STOPCOCK WAS THEN REMOVED AND THE INFLATION DEVICE WAS CONNECTED DIRECTLY TO THE BALLOON WITHOUT THE STOPCOCK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE ALLEGED MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9831048 ↗
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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