510(k) Report

FDA applicant

Syncardia Systems, LLC

Tucson1 decision2004–20045 recalls

FDA records 1 decision for Syncardia Systems, LLC (Tucson) in 2004: 1 original PMA approval. All are in product code LOZ (Artificial Heart). 5 recalls are linked to its devices, 2 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Syncardia Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Syncardia Systems, LLC since 2007.

Recalls per year

1in 2023

2012: 12015: 1, 1 Class I2016: 1, 1 Class I2022: 12023: 1
2007high 1 (2012) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Syncardia Systems, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LOZArtificial Heart1decision

What has FDA decided for it lately?

  • P030011Syncardia Temporary Cardio West Total Artificial Heart (Tah-T)Syncardia Systems, LLC · 20042 Class I recalls

The one decision as Syncardia Systems, LLC →

What has been recalled?

5 recalls linked to its devices; the latest:

  • P030011SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EOAug 1, 2023Class II
  • P030011SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial…Nov 2, 2022Class II
  • P0300115000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart…Oct 21, 2016Class I
  • P030011Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001…Aug 6, 2015Class I
  • P030011Companion External Battery, Part Number: 293001-001 The Companion External Battery is a…Dec 5, 2012Class II