Syncardia Systems, LLC
FDA adverse event reports naming Syncardia Systems, LLC as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: SYNCARDIA SYSTEMS, LLC.
- Total reports
- 2,333
- Deaths
- 335
- Injuries
- 257
- Malfunctions
- 1,741
Reports per year
Source: FDA adverse event reports by year received, 2015–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Artificial HeartLOZ2,333
Recent recalls
- 2023-10-20CompletedOther
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
- 2023-01-27Open, ClassifiedDevice Design
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Due to tears reported tears in the cannula due to wear and tear stress.
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