REVACLEAR Revaclear 400Recalls & reported problems
Gambro Dialysatoren GmbH · Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by Hemodialysis. · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07332414126209), received between Oct 10, 2024 and Oct 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Nov 23, 2022Open, Classified
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Z-0763-2023 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT AN EXTERNAL FLUID LEAK WAS OBSERVED FROM ONE END OF A REVACLEAR 400 DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416852 ↗
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.