FARASTAR Ablation Generator EU — Class II medical device recall Z-2753-2026
Ongoing recall by Boston Scientific Corporation, reported 2026-07-29. Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compati
| Recall number | Z-2753-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Saint Paul, MN, United States |
| Recall initiated | 2026-06-11 |
| Classified | 2026-07-17 |
| Reported by FDA | 2026-07-29 |
| Countries outside the US | AT, BE, DE, FR, IT |
| Quantity | 6 units |
| UPC / GTIN / UDI-DI | 00810087180126 |
| Serial numbers | 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172 |
Product
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Reason for recall
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
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-2753-2026. 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.