5008X Hemodialysis Machine M204441Recalls & reported problems
Fresenius Medical Care Renal Therapies Group, LLC · 5008X CAREsystem with CLiC and CDX · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840861102433), received between Jul 6, 2026 and Sep 28, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Thermal Decomposition of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Oct 25, 2025Class IIOpen, Classified
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Z-0936-2026 · Root cause: Software design · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem3
- Thermal Decomposition of Device1
Patient problems
- Cardiac Arrest2
- Low Blood Pressure/ Hypotension1
- No Clinical Signs, Symptoms or Conditions1
- Syncope/Fainting1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Thermal Decomposition of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917600 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Cardiac Arrest
MAUDE report 50812401 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Cardiac Arrest
MAUDE report 50812400 ↗InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT BECAME UNRESPONSIVE DURING HEMODIALYSIS TREATMENT UTILIZING THE FRESENIUS 5008 X HEMODIALYSIS MACHINE. THE PATIENT WAS REVIVED AND THAT PER AUTOMATIC EXTERNAL DEFIBRILLATOR (AED) NO SHOCK WAS ADVISED. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE CHARGE HEMODIALYIS NURSE AND THE BIOMEDICAL TECHNICIAN AT THE USER FACILITY. PER THE NURSE, ON (B)(6) 2026, THE PATIENT ARRIVED AT CLINIC FOR THEIR REGULARLY SCHEDULED HEMODIALYSIS TREATMENT. THE PATIENT HAS A PRESCRIBED DIALYSIS TREATMENT TIME OF 3 HOURS AND 45 MINUTES AND A PRESCRIBED DRY WEIGHT OF 57 KG. THE PATIENT¿S PRE-DIALYSIS VITAL SIGNS INCLUDED BLOOD PRESSURE OF 163/69 MM/HG, PULSE OF 69 AND PRE-DIALYSIS WEIGHT OF 59.6KG. IT WAS REPORTED THAT THE FRESENIUS 5008X MACHINE PASSED ALL PRE-TREATMENTS TESTING WITHOUT ANY INDICATION OF ANY MACHINE ISSUES. PER THE NURSE, THE PATIENT¿S TREATMENT WAS INITIATED WITHOUT ANY ISSUES. HOWEVER, APPROXIMATELY 3 HOURS AND 28 MINUTES INTO THE HEMODIALYSIS TREATMENT THE PATIENT HAD A HYPOTENSIVE EVENT. IT WAS CONFIRMED THAT THE PATIENT¿S BLOOD PRESSURE DECREASED TO 77/40 MM/HG WITH A PULSE OF 94 WITH A LOSS OF CONSCIOUSNESS (SYNCOPE). AS A RESULT, THE
Patient problems: Low Blood Pressure/ Hypotension; Syncope/Fainting
MAUDE report 25719904 ↗
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 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 · each recall links to the FDA recall notice
- 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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