LivaNova Deutschland GmbH
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0571-2025 | Class II | Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software | October 18, 2024 |
| Z-0073-2024 | Class II | 3T Heater Cooler System, REF: 16-02-85 | August 3, 2023 |
| Z-0787-2022 | Class III | Sorin Centrifugal Pump System, CP5, Drive Unit (Catalogue Item #60-01-04, UDI: 04033817900948) used | December 17, 2021 |
| Z-2440-2020 | Class II | Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI: | August 26, 2019 |
| Z-2439-2020 | Class II | Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UD | August 26, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232291 | Essenz HLM, Essenz ILBM | August 24, 2023 |
| K221373 | Essenz HLM | March 9, 2023 |
| K220635 | Heater-Cooler System 3T | November 16, 2022 |
| K212003 | ESSENZ Patient Monitor | November 10, 2021 |
| K210130 | Stockert S5 System | April 5, 2021 |
| K202154 | B-Capta | April 1, 2021 |
| K191402 | Heater-Cooler System 3T | February 25, 2020 |