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FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401

FDA Recall #Z-2278-2025 — Class II — June 25, 2025

Recall #Z-2278-2025 Date: June 25, 2025 Classification: Class II Status: Ongoing

Product Description

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.

Recalling Firm

Boston Scientific Corporation — Saint Paul, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

445 units

Distribution

US Nationwide.

Code Information

UDI-DI: 00191506043148; Batch Numbers: 36543581 36543644 36543646 36568553 36572565 36572568 36572571 36572576 36578308 36578314 36579110 36598352 36598809 36599402 36600406 36600543 36600544 36600545 36600578

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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