SynCardia Systems Inc.
Summary
- Total Recalls
- 5 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 5
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0126-2024 | Class II | SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO | August 1, 2023 |
| Z-1022-2023 | Class II | SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart Syste | November 2, 2022 |
| Z-0659-2017 | Class I | 5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). P | October 21, 2016 |
| Z-2731-2015 | Class I | Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usa | August 6, 2015 |
| Z-0620-2013 | Class II | Companion External Battery, Part Number: 293001-001 The Companion External Battery is a component | December 5, 2012 |