Thoratec Switzerland GMBH
FDA Regulatory Profile
Summary
- Total Recalls
- 3 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2215-2024 | Class II | 2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300 | May 22, 2024 |
| Z-0221-2020 | Class I | CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a compo | August 22, 2019 |
| Z-0103-2019 | Class II | Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System | September 5, 2018 |