CAPIOX® HEMOCONCENTRATOR CX*HC11LRecalls & reported problems
Terumo Corporation · Class 2
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04987350738417), received between Jul 24, 2017 and Jan 20, 2020 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 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
- Physical Resistance/Sticking3
- Filtration Problem2
- Device Inoperable1
- Infusion or Flow Problem1
Patient problems
- No Information5
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 20, 2020Physical Resistance/Sticking; Physical Resistance/Sticking
THE USER FACILITY REPORTED THAT THE CAPIOX HEMCONCENTRATOR WAS STUCK AND THERE WAS NO FUNCTION DURING BYPASS AFTER TWO HOURS. THEY CHANGED OUT THE DEVICE TO A NEW ONE TO ALLOW THE PROCEDURE TO KEEP GOING UNTIL THE END. THE PROCEDURE OUTCOME AND PATIENT IMPACT WAS REPORTED TO BE UNKNOWN.
Patient problems: No Information
MAUDE report 9606485 ↗MalfunctionJan 20, 2020Physical Resistance/Sticking; Physical Resistance/Sticking
THE USER FACILITY REPORTED THAT THE CAPIOX HEMOCONCENTRATOR WAS STUCK AND THERE WAS NO FUNCTION DURING BYPASS AFTER TWO HOURS. THEY CHANGED OUT THE DEVICE TO A NEW ONE TO ALLOW THE PROCEDURE TO KEEP GOING UNTIL THE END. THE PROCEDURE OUTCOME AND PATIENT IMPACT WAS REPORTED TO BE UNKNOWN.
Patient problems: No Information
MAUDE report 9606474 ↗MalfunctionJan 20, 2020Physical Resistance/Sticking; Physical Resistance/Sticking
THE USER FACILITY REPORTED THAT THE CAPIOX HEMCONCENTRATOR WAS STUCK AND THERE WAS NO FUNCTION DURING BYPASS AFTER TWO HOURS. THEY CHANGED OUT THE DEVICE TO A NEW ONE TO ALLOW THE PROCEDURE TO KEEP GOING UNTIL THE END. THE PROCEDURE OUTCOME AND PATIENT IMPACT WAS REPORTED TO BE UNKNOWN.
Patient problems: No Information
MAUDE report 9606473 ↗MalfunctionApr 26, 2019Filtration Problem; Filtration Problem
THE USER FACILITY REPORTED THAT THE INVOLVED CAPIOX HEMOCONCENTRATOR WAS STUCK AND THERE WAS NO FUNCTION DURING BYPASS AFTER 4HRS. THEY CHANGED TO A NEW ONE TO ALLOW THE PROCEDURE KEEP GOING UNTIL THE END. THE PATIENT IMPACT AND PROCEDURE OUTCOME WAS REPORTED TO BE UNKNOWN.
Patient problems: No Information
MAUDE report 8556570 ↗MalfunctionApr 26, 2019Filtration Problem; Filtration Problem
THE USER FACILITY REPORTED THAT AFTER 4.5 HRS THE INVOLVED CAPIOX HEMOCONCENTRATOR WAS STUCK, THE PROCEDURE WAS REPORTED TO BE THE SAME AS USUAL. THEY CHANGED TO A NEW ONE TO CONTINUE THE BYPASS SURGERY. THE PATIENT IMPACT AND PROCEDURE OUTCOME WAS REPORTED TO BE UNKNOWN.
Patient problems: No Information
MAUDE report 8556567 ↗MalfunctionJul 24, 2018Infusion or Flow Problem; Infusion or Flow Problem
THE USER FACILITY REPORTED THE BYPASS PRIME VOLUME WAS NORMAL, SALINE AND SUITABLE ANTICOAGULANT KEPT AT HCT 25%, BY ORDER ULTRAFILTRATION FLOW 150-200 ML/MIN. AFTER 5 MINUTES THERE WAS HEMOCONCENTRATOR FAILURE. THE ACTUAL SAMPLE WAS CHANGED OUT TO A NEW HEMOCONCENTRATOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7714141 ↗MalfunctionJul 24, 2017Device Inoperable; Device Inoperable
THE USER FACILITY REPORTED AN ISSUE WITH THE CAPIOX HEMOCONCENTRATOR DEVICE DURING A PROCEDURE. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: IT WAS REPORTED THE FILTER FUNCTION DID NOT WORK; AND THE PERFUSIONIST IMMEDIATELY CHANGED THE DEFECT SAMPLE TO A NEW ONE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6735712 ↗
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.