Blood Circuit Set UF 500Recalls & reported problems
Gambro Uf Solutions, Inc · The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. · Class 2
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 07332414112387), received between Sep 26, 2018 and Oct 26, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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
- Fluid/Blood Leak4
Patient problems
- Blood Loss4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 26, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THERAPY WITH THE AQUADEX FLEXFLOW SYSTEM, A BLOOD LEAK WAS DETECTED WITHIN THE UF 500 BLOOD CIRCUIT. THE FACILITY REPORTED THAT THE BLOOD LEAK OCCURRED SHORTLY AFTER TREATMENT BEGAN WITH THE CIRCUIT. THE UF 500 BLOOD CIRCUIT WAS REPLACED WITH A NEW CIRCUIT AND THERAPY WAS RESUMED.
Patient problems: Blood Loss
MAUDE report 8009693 ↗MalfunctionOct 17, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THERAPY WITH THE AQUADEX FLEXFLOW SYSTEM, A BLOOD LEAK WAS DETECTED. THE BLOOD LEAK OCCURRED WITHIN THE UF 500 BLOOD CIRCUIT. THE FACILITY REPORTED THAT THE BLOOD LEAK OCCURRED WITHIN 20 MINUTES OF CIRCUIT USE. THE UF 500 BLOOD CIRCUIT WAS REPLACED WITH A NEW CIRCUIT AND THERAPY WAS RESUMED.
Patient problems: Blood Loss
MAUDE report 7975671 ↗MalfunctionSep 27, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THERAPY WITH THE AQUADEX FLEXFLOW SYSTEM, A BLOOD LEAK WAS DETECTED. THE BLOOD LEAK OCCURED WITHIN THE UF 500 BLOOD CIRCUIT. THE FACILITY REPORTED THAT THE BLOOD LEAK OCCURRED AFTER TWO HOURS OF CIRCUIT USE. THE UF 500 BLOOD CIRCUIT WAS REPLACED WITH A NEW CIRCUIT AND THERAPY WAS RESUMED.
Patient problems: Blood Loss
MAUDE report 7915531 ↗MalfunctionSep 26, 2018Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING THERAPY WITH THE AQUADEX FLEXFLOW SYSTEM, A BLOOD LEAK WAS DETECTED. THE BLOOD LEAK OCCURRED WITHIN THE UF 500 BLOOD CIRCUIT. THE FACILITY REPORTED THAT THE BLOOD LEAK OCCURRED AFTER TWO HOURS OF CIRCUIT USE. THE UF 500 BLOOD CIRCUIT WAS REPLACED WITH A NEW CIRCUIT AND THERAPY WAS RESUMED.
Patient problems: Blood Loss
MAUDE report 7912087 ↗
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- 2008T BlueStar Hemodialysis Machine 191130Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls7 deaths272 reports
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- Optiflux® 0500320EFresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system2 recalls242 reports
- REVACLEAR 300Gambro Renal Products, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls125 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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