FARAWAVE 1 — Class II medical device recall Z-2278-2025
Ongoing recall by Boston Scientific Corporation, reported 2025-08-20, distributed nationwide. The potentially impacted units were manufactured using specific equipment that may have caused cracks in the e
| Recall number | Z-2278-2025 |
|---|---|
| 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 | 2025-06-25 |
| Classified | 2025-08-08 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 445 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00191506043148 |
| Lot numbers | 36543581, 36543644, 36543646, 36568553, 36572565, 36572568, 36572571, 36572576, 36578308, 36578314, 36579110, 36598352, 36598809, 36599402, 36600406, 36600543, 36600544, 36600545, 36600578 |
Product
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Reason for recall
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
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-2278-2025. 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.