Hemodialysis System For Home Use
FDA adverse event reports and recall history for hemodialysis system for home use (product code ONW), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 137
- Deaths
- 25
- Injuries
- 20
- Malfunctions
- 92
Reports per year
Source: FDA adverse event reports by year received, 2012–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2013-11-08TerminatedLabeling design
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
- 2013-11-08TerminatedLabeling design
Combiset Blood Line with BVM for Hemodialysis use Catalog Number: 03-2965-9. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
- 2013-11-08TerminatedLabeling design
Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodialysis and is indicated for use with conventional and high flux negative pressure hemodialyzer equipment.
Updated Instructions for Use: Bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss
- 2011-08-29TerminatedDevice Design
Fresenius 2008K@home The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.
Upgrade software to implement new on screen graphics and instructions, the addition of a bracket on the side of the machine to temporarily hold the bloodlines during set up in order to conform to approved 510(k)
Monitor hemodialysis system for home use automatically
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