UltraxxRecalls & reported problems across all models
Cook Incorporated · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 0
We found 9 models of Ultraxx by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 25 adverse event reports in the FDA's MAUDE database, received between Jul 15, 2016 and Dec 9, 2025 — classified as 1 injury, 24 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (11 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Ultraxx problems
Device problems
- Material Rupture11
- Fluid/Blood Leak3
- Leak/Splash3
- Difficult to Advance2
- Material Separation2
- Device Contaminated During Manufacture or Shipping1
- Device Contamination with Chemical or Other Material1
- Device Operates Differently Than Expected1
Patient problems
- No Consequences Or Impact To Patient11
- No Clinical Signs, Symptoms or Conditions10
- Insufficient Information2
- No Code Available1
- No Known Impact Or Consequence To Patient1
- Renal Failure1
Ultraxx models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ultraxx G46033CATHETER, NEPHROSTOMY6 reports
- Ultraxx G30365CATHETER, NEPHROSTOMY5 reports
- Ultraxx G46037CATHETER, NEPHROSTOMY4 reports
- Ultraxx G46036CATHETER, NEPHROSTOMY3 reports
- Ultraxx G30357CATHETER, NEPHROSTOMY2 reports
- Ultraxx G47649CATHETER, NEPHROSTOMY2 reports
- Ultraxx G30364CATHETER, NEPHROSTOMY1 report
- Ultraxx G46023CATHETER, NEPHROSTOMY1 report
- Ultraxx G46038CATHETER, NEPHROSTOMY1 report
Recent Ultraxx adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2025Difficult to Advance; Difficult to Advance
ADDITIONAL INFORMATION WAS RECEIVED 20FEB2026. PER THE REPORTER, IT IS UNKNOWN WHAT PRESSURE/VOLUME WAS THE BALLOON INFLATED TO. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER 'ULTRAXX NEPHROSTOMY BALLOON AND SET'.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23756000 ↗MalfunctionAug 8, 2024Difficult to Advance; Difficult to Advance
AS REPORTED, THE ULTRAXX NEPHROSTOMY BALLOON AND SET'S SHEATH TIP "CURLED" AND COULD NOT BE INSERTED DURING AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETE WITH A NEW DEVICE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19945691 ↗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 ↗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 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 ↗MalfunctionMar 24, 2022Material Separation; Difficult to Open or Remove Packaging Material; Material Separation; Difficult to Open or Remove Packaging Material
AS INITIALLY REPORTED, DURING RETROGRADE INTRARENAL SURGERY (RIRS), THE INNER PROTECTIVE TUBING COULD NOT BE REMOVED FROM THE SHEATH OF AN ULTRAXX NEPHROSTOMY BALLOON. THE ISSUE WITH THIS DEVICE WAS DISCOVERED PRIOR TO MAKING CONTACT WITH THE PATIENT AND IT WAS NOT USED. A NEW SAME TYPE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS RETURNED TO THE MANUFACTURER 08MAR2022 WITH THE BALLOON IN TWO SEPARATE PIECES. 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 13876061 ↗MalfunctionMar 4, 2022Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED, DURING A PERCUTANEOUS NEPHROLITHOTOMY, A ULTRAXX NEPHROSTOMY BALLOON COULD NOT BE INFLATED DUE TO LEAKAGE. AN AMPLATZ DILATOR WAS USED TO COMPLETE THE PROCEDURE WITH GOOD OUTCOME FOR THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13666217 ↗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 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 ↗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 ↗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 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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