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

FDA device recall Z-2750-2026 · posted 2026-07-17 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Action taken

Boston Scientific issued an Urgent Field Safety Notice - Urgent Medical Device Correction 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: 1- Post a copy of the appropriate IFU provided near each FARASTAR PFA generator, replacing any previous versions currently in use. 2- Review the IFU and ensure all relevant personnel are aware of its contents. 3- Please complete the attached Acknowledgement Form even if you do not have any affected product and return it to your Boston Scientific office. 4- Share this communication with any healthcare professionals in your facility that use the product and with any other organization to which this product may have been transferred. The national Competent Authority was informed of this communication. Any adverse events or quality concerns associated with use of these devices should be reported to Boston Scientific and Competent Authorities if appropriate.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

QZI

Quantity affected

18 units

Distribution

International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.

Date initiated

2026-06-11

Date posted

2026-07-17

Location

Saint Paul, MN