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

FDA device recall Z-2753-2026 · posted 2026-07-17 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

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.

Action taken

Boston Scientific issued an Urgent Field Safety Notice - Urgent Medical Device Recall notice to its consignees out side the US on 6/11/2026 via hand delivered letter. The notice explained the issue and requested the following actions be taken: Instructions: 2- Allow Boston Scientific representative(s) to replace affected FARASTAR PFA generators. 3- Please complete the attached Verification Form even if you do not have any product to return and send it to your local Boston Scientific office 4- If you have products to return, please package them in an appropriate shipping box. After receipt of the Verification Form, Boston Scientific will contact you to arrange return. 6- Please pass this notice to any health professional from your organization that needs to be aware, and to any organization where the potentially affected devices have been transferred (if appropriate). Please provide Boston Scientific with details of any affected devices that have been transferred to other organizations (if appropriate). The National Competent Authority has been informed of this communication.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QZI

Quantity affected

6 units

Distribution

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

Date initiated

2026-06-11

Date posted

2026-07-17

Location

Saint Paul, MN