CW ClaimWatch Consumer alert tracker

Recall

Boston Scientific Corporation: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter Recall

Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. Product details: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter

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Agency
FDA
Record ID
Z-2753-2026
Canonical
https://claimwatch-mvp.vercel.app/item/boston-scientific-corporation-farastar-ablation-generator-eu-pulsed-field-ablation-generat/

What happened?

Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. Product details: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter

Who may be affected?

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

What should consumers do?

Affected quantity: 6 units

Official source

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No. This page is informational. Always confirm eligibility, deadlines, and safety instructions through official sources.

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