Syncardia Systems recalls
Syncardia Systems appears in 5 official U.S. recall notices indexed by RecallRadar, most recently on 2023-11-01.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
FDA Device · Class II · 2023-11-01 · Syncardia Systems - SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
FDA Device · Class II · 2023-02-08 · Syncardia Systems - 5000 Series Freedom Drivers
FDA Device · Class I · 2016-12-14 · Syncardia Systems - Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the Syn…
FDA Device · Class I · 2015-09-23 · Syncardia Systems - Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component of the Companion 2 Driver System and the…
FDA Device · Class II · 2013-01-09 · Syncardia Systems