Cardiac Assist, Inc
Cardiac Assist, Inc appears in FDA public data with 14 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 4 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-2465-2023, Class II) was initiated on June 30, 2023.
Summary
- Total Recalls
- 14 (2 Class I)
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2465-2023 | Class II | LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part numbe | June 30, 2023 |
| Z-0926-2023 | Class I | SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY | December 5, 2022 |
| Z-1763-2022 | Class I | TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller | July 21, 2022 |
| Z-0311-2022 | Class III | SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the fol | October 14, 2021 |
| Z-1486-2021 | Class II | Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840 | March 19, 2021 |
| Z-1951-2020 | Class II | TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: | March 6, 2020 |
| Z-1950-2020 | Class II | TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product U | March 6, 2020 |
| Z-1953-2020 | Class II | TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usag | March 6, 2020 |
| Z-1952-2020 | Class II | TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: | March 6, 2020 |
| Z-1954-2020 | Class II | TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: | March 6, 2020 |
| Z-1948-2020 | Class II | TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circula | March 6, 2020 |
| Z-1949-2020 | Class II | TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Us | March 6, 2020 |
| Z-1955-2020 | Class II | TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: prov | March 6, 2020 |
| Z-1106-2020 | Class II | TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of | November 19, 2019 |