FARASTAR PFA Generator — Class II medical device recall Z-2752-2026
Ongoing recall by Boston Scientific Corporation, reported 2026-07-29. Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA cathet
| Recall number | Z-2752-2026 |
|---|---|
| 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, DE, DK, ES, FR, GB, IE, IT, PT |
| Quantity | 11 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00191506043643 |
| Serial numbers | 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816 |
Product
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter
Reason for recall
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
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-2752-2026. 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.