Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
FDA adverse event reports and recall history for normothermic machine perfusion system for the preservation of donor livers prior to transplantation (product code QQK), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 470
- Deaths
- 2
- Injuries
- 116
- Malfunctions
- 352
Reports per year
Source: FDA adverse event reports by year received, 2024–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-11-21Open, ClassifiedDevice Design
OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx metra is a transportable device intended to be used to sustain donor livers destined for transplantation in a functioning state for a total preservation time of up to 12 hours.
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
Monitor normothermic machine perfusion system for the preservation of donor livers prior to transplantation automatically
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