Ultrafilter U 9000 112062Recalls & reported problems
Gambro Dialysatoren GmbH · The U9000 Ultrafilter is indicated for purification of incoming water for dialysis fluid as well as purification of dialysis fluid to obtain microbiological high quality dialysis fluid. The risk of exposure to bacteria and endotoxins can thereby be minimized. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07332414102500), received between Jul 20, 2023 and Jun 19, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM AN ULTRAFILTER U9000 PRIOR TO USE. THE FILTER HAD BEEN USED 78 TIMES FOR HEMODIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289518 ↗MalfunctionMay 20, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM AN ULTRAFILTER U9000 DURING AN UNSPECIFIED PROCESS STEP. THE FILTER WAS USED IN AN AK98 MACHINE 123 TIMES IN 47 DAYS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22054115 ↗MalfunctionJan 7, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM TWO (2) U9000 ULTRAFILTERS DURING HEMODIALYSIS THERAPY WITH AN AK95 MACHINE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21096025 ↗MalfunctionJun 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED FROM AN UNSPECIFIED LOCATION OF AN ULTRAFILTER U9000 DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19463688 ↗MalfunctionNov 14, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING FROM UNKNOWN LOCATION ON A U9000 SET DURING HEMODIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18133182 ↗MalfunctionJul 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED IN U9000 ULTRAFILTER DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17367428 ↗
Other Subsystem, water purification devices
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- AquaBplus AquaBplus B2 2500VIVONIC GmbH · Subsystem, Water Purification1 recall0 reports
- AquaBplus & AquaBplus B2 & AquaBplus HF 2500VIVONIC GmbH · Subsystem, Water Purification1 recall0 reports
- TabloCart™ with Prefiltration Drawer PN-0006813Outset Medical, Inc. · Subsystem, Water Purification1 recall0 reports
- AquaA AquaA 900HVIVONIC GmbH · Subsystem, Water Purification1 recall0 reports
- Millenium HX RO,MILLENIUM HX,750GPD,115~,60HZMar Cor Purification, Inc. · Subsystem, Water Purification3 reports
- CWP RO,CWP,28LPM,104HMar Cor Purification, Inc. · Subsystem, Water Purification2 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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