Ultraxx G46037Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002460379), received between Jul 15, 2016 and Jun 12, 2019 — classified as 4 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
Device problems
- Material Rupture2
- Hole In Material1
- Leak/Splash1
- Material Integrity Problem1
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2019Material Integrity Problem; Material Integrity Problem
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 8692376 ↗MalfunctionNov 9, 2018Material Rupture; Material Rupture
IT WAS REPORTED A PERCUTANEOUS NEPHROLITHOTOMY (PNL) AND EXCHANGE OF NEPHROSTOMY CATHETER WAS PERFORMED. THE PHYSICIAN INCISED FASCIA AT FIRST AND THEN, ADVANCED A BALLOON CONTAINED IN THE ULTRAXX NEPHROSTOMY BALLOON AND SET OVER A WIRE GUIDE PERCUTANEOUSLY. HE ATTEMPTED TO DILATE THE NEPHROSTOMY FROM 10 FRENCH SIZE TO 18 FRENCH SIZE WITH THE BALLOON TO MAKE A TRACT FOR AN ENDOSCOPE. ALTHOUGH THE BALLOON DID NOT TOUCH A RENAL STONE, IT WAS RUPTURED DURING INFLATION. HE USED A FASCIAL DILATOR (MADE OF METAL) INSTEAD AND THE DILATION OF THE FISTULA COULD BE COMPLETED SUCCESSFULLY. AFTER THAT, PNL WAS PERFORMED, CATHETER WAS EXCHANGED AS PLANNED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8055114 ↗MalfunctionSep 7, 2016Hole In Material; Leak/Splash; Hole In Material; Leak/Splash
IT WAS REPORTED THAT DURING A PERCUTANEOUS NEPHROLITHOTOMY PROCEDURE ON A (B)(6) YEAR OLD FEMALE PATIENT, THERE WAS A HOLE IN THE DISTAL TIP OF THE BALLOON, CAUSING IT TO LEAK. THE BALLOON REMAINED INTACT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5932179 ↗MalfunctionJul 15, 2016Material Rupture; Material Rupture
IT WAS REPORTED A COOK ULTRAXX NEPHROSTOMY BALLOON WAS USED FOR A CYSTOSTOMY CATHETER EXCHANGE AND THE BALLOON WAS INFLATED SUCCESSFULLY AT THE TARGET SITE. HOWEVER, THE BALLOON RUPTURED WHEN THE USER ADVANCED A SUPPLIED CLEAR SHEATH OVER THE BALLOON. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 5798015 ↗
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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