2nd Generation CentriMag Primary Console — Class II medical device recall Z-2215-2024
Ongoing recall by Thoratec Switzerland GMBH, reported 2024-07-03, distributed nationwide. Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4
| Recall number | Z-2215-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec Switzerland GMBH, Zurich, Switzerland |
| Recall initiated | 2024-05-22 |
| Classified | 2024-06-27 |
| Reported by FDA | 2024-07-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BG, CA, CH, CL, CO, CR, CZ, DE, DK, DO, DZ, EE, ES, FI, FR, GB, GR, HK, IL, IN, IQ, IR, IT, KE, KR, KW, KY, LT, MA, MX, MY, NL, NO, OM, PE, PL, PT, QA, RO, RU, SA, SE, SG, SI, TH, TN, TW, ZA |
| Quantity | 3,425 |
| UPC / GTIN / UDI-DI | 05415067037282, 07640135140689, 07640135140702, 07640135140719, 07640135140726, 07640135140856, 07640135140894, 07640135149002, 07640135149019 |
| Model numbers | 201-30300, 201-90401, 201-90411, 201-90421, 201-90701, L201-90401, L201-90411, L201-90421 |
Product
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System
Reason for recall
Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2215-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.