FDA recall Z-2753-2026

Product

FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter

Reason for recall

Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.

Distribution

International distribution in the countries of Italy, Austria, France, Germany, Belgium.

Key facts

Status

Ongoing

Initiation date

2026-06-11

Report date

2026-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2753-2026