CW ClaimWatch Consumer alert tracker

Recall

Boston Scientific Corporation: FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter Recall

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. Product details: FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter

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Agency
FDA
Record ID
Z-2751-2026
Canonical
https://claimwatch-mvp.vercel.app/item/boston-scientific-corporation-farastar-pulsed-field-ablation-generator-product-id-m004pfce/

What happened?

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. Product details: FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter

Who may be affected?

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

What should consumers do?

Affected quantity: 1 units

Official source

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Is this legal, medical, or financial advice?

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

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