Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end. |
| Product | FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 |
| Quantity | 445 units |
| Distribution | US Nationwide. |
| Initiated | 2025-06-25 |
| Classified | 2025-08-08 |
| Recall number | Z-2278-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-2278-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97207/
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