Thoratec Switzerland GMBH
FDA Regulatory Profile
Thoratec Switzerland GMBH has 3 FDA recalls (1 Class I), 2 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-2215-2024 · Class II · May 22, 2024
- Latest inspection
- May 24, 2018 · NAI
Newer recall under related name Abbott: Sep 10, 2026, Z-0191-2027.
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 3 (1 Class I) | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 2 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|
Abbott
Same company group | 22 | 13 | 17 | 0 | Sep 10, 2026 (Z-0191-2027) |
Alere San Diego
Same company group | 53 | 1 | 9 | 1 | Aug 20, 2026 (Z-3274-2026) |
Thoratec
Same company group | 24 | 1 | 10 | 1 | May 13, 2026 (Z-2520-2026) |
Abbott Medical
Same company group | 43 | 60 | 53 | 5 | May 12, 2026 (Z-2405-2026) |
Abbott Point Of Care
Same company group | 31 | 22 | 2 | 0 | Apr 1, 2026 (Z-2001-2026) |
Abbott Diagnostics Scarborough
Same company group | 7 | 7 | 7 | 0 | Feb 9, 2026 (Z-1565-2026) |
Abbott Diabetes Care
Same company group | 18 | 40 | 14 | 2 | Nov 24, 2025 (Z-1023-2026) |
Abbott Laboratories
Same company group | 156 | 890 | 161 | 3 | Nov 13, 2025 (Z-0961-2026) |
Abbott Molecular
Same company group | 36 | 19 | 16 | 1 | Apr 28, 2025 (Z-1749-2025) |
Abbott Vascular
Same company group | 42 | 50 | 37 | 0 | Nov 6, 2024 (Z-0733-2025) |
Abbott Diagnostics Technologies
Same company group | 2 | 1 | 1 | 0 | Jun 17, 2024 (Z-2736-2024) |
Abbott Ireland Limited
Same company group | 1 | 0 | 3 | 0 | Apr 24, 2023 (Z-1696-2023) |
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… | May 22, 2024 |
| Z-0221-2020 | Class I | CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a… | Aug 22, 2019 |
| Z-0103-2019 | Class II | Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System… | Sep 5, 2018 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3003306248 | Zurich, Switzerland | 2 | May 24, 2018 |