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SynCardia Systems LLC
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Type Company Card addedAugust 10 Threat lists flagged Reviews1
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Threat lists · flagged Product safety recall
Official safety regulators published alerts about a product of this kind.
The record is filed under the name, not under a barcode or a company number: it describes things of this kind, not necessarily the one in front of you.
Alerts on record1 HazardArtificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. First alertAugust 1, 2023 Latest alertAugust 1, 2023 On our lists sinceAugust 10, 2026
What to do: Check the maker, the batch and the date of the exact item you have — the alert is about this kind of product.
Where this came from: openFDA device recalls — An official government safety register — product recalls and safety alerts.
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Reviews · 1
SynCardia Systems LLC is all about mechanical heart support, especially the Total Artificial Heart for patients whose own heart can no longer do the job. By our assessment, that makes it a highly specialized medical-device company, not a broad cardiology brand. Its main strength is obvious: it exists for an extreme clinical problem, where there are few alternatives and the engineering has to be exact. The trade-off is equally clear, because this kind of therapy is complex, heavily monitored, and far from routine care. In practice, SynCardia Systems LLC lives in transplant centers and critical-care environments, where setup, follow-up, and patient selection matter as much as the device itself. It sits at the very narrow edge of cardiac support technology, beside far bigger companies that make pumps and implants for more common cases. The ceiling is not market size so much as how rare and demanding the use case is.
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