FDA recall Z-2278-2025

Boston Scientific Corporation · Class II · device

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

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

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