REVACLEAR Revaclear 300Recalls & reported problems
Gambro Dialysatoren GmbH · Revaclear 300 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis. · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07332414126193), received between Aug 12, 2022 and Sep 20, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Crack1
- Fracture1
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 20, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
IT WAS REPORTED AN EXTERNAL SALINE SOLUTION LEAK WAS OBSERVED ORIGINATING FROM THE ARTERIAL PORT OF A REVACLEAR 300 SET DURING PRIME. UPON FURTHER INSPECTION, THE PORT WAS NOTED TO BE ¿FRACTURED¿. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17782440 ↗MalfunctionAug 7, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED AN EXTERNAL FLUID LEAK WAS OBSERVED ORIGINATING AT THE VENOUS SIDE OF A REVACLEAR 300 SET DURING PRIME. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17477476 ↗MalfunctionAug 12, 2022Crack; No Flow
UPON INITIATION OF DIALYSIS A CRACK WAS NOTED IN DIALYZER. UNABLE TO RETURN BLOOD TO PATIENT. PATIENT LOST APPROXIMATELY 183CC OF BLOOD. DOCTOR WAS AWARE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15216988 ↗
Other Dialyzer, high permeability with or without sealed dialysate system devices
- Optiflux® 0500318EFresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system1 recall6 deaths2,849 reports
- 2008® Series Hemodialysis Machines 190713Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls37 deaths893 reports
- 2008T BlueStar Hemodialysis Machine 191126Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system5 recalls10 deaths441 reports
- 2008® Series Hemodialysis Machines 190766Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls15 deaths370 reports
- 2008T BlueStar Hemodialysis Machine 191130Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls7 deaths272 reports
- 2008® Series Hemodialysis Machines 190610Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system1 recall15 deaths335 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.