Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
FDA adverse event reports and recall history for separator for therapeutic purposes, membrane automated blood cell/plasma (product code MDP), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 213
- Deaths
- 8
- Injuries
- 72
- Malfunctions
- 133
Reports per year
Source: FDA adverse event reports by year received, 2003–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-02-02Open, ClassifiedComponent design/selection
PRISMAFLEX TPE2000 SET, Product Code 114093; 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.
- 2014-08-13TerminatedDevice Design
Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
- 2014-08-13TerminatedDevice Design
Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
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