Dialyzer, High Permeability With Or Without Sealed Dialysate System
FDA adverse event reports and recall history for dialyzer, high permeability with or without sealed dialysate system (product code KDI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 43,339
- Deaths
- 2,581
- Injuries
- 12,192
- Malfunctions
- 27,885
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-07-08Open, ClassifiedProcess control
5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and descriptions. 1. 5008X HD Pre-Flush Standard Blood Tubing Set; Model Number: 03-5110-6. 2. 5008X HD Pre-Flush With Twister Blood Tubing Set; Model Number: 03-5160-1. 3. 5008X HD/HDF Standard Blood Tubing Set; Model Number: 03-5300-3. 4. 5008X HD/HDF With CLiC Blood Tubing Set; Model Number: 03-5300-3C. 5. 5008X HD/HDF With Twister Blood Tubing Set; Model Number: 03-5350-8.
Potential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the 5008X CAREsystem.
- 2026-02-02Open, ClassifiedComponent design/selection
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2026-02-02Open, ClassifiedComponent design/selection
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2026-02-02Open, ClassifiedComponent design/selection
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2026-02-02Open, ClassifiedComponent design/selection
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2026-02-02Open, ClassifiedComponent design/selection
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2026-02-02Open, ClassifiedComponent design/selection
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2026-02-02Open, ClassifiedComponent design/selection
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
- 2025-12-17Open, ClassifiedSoftware design
5008X CAREsystem +CLiC +CDX;
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.
- 2025-12-11Open, ClassifiedDevice Design
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
Screw may loosen or fallout of Hemodialysis system
Monitor dialyzer, high permeability with or without sealed dialysate system automatically
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