# FDA recall Z-2278-2025

> **Boston Scientific Corporation** · Class II · device recall initiated 2025-06-25.

## 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.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-2278-2025
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-25
- **Report date:** 2025-08-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2278-2025

## Citation

> AI Analytics. FDA recall Z-2278-2025. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-2278-2025. Source: US FDA. Licensed CC0.

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