Is Boston Scientific Corporation recalled?

Yes — a recall has been published. Reason: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

TemporaryFDAOngoing

Can cause harm that is usually temporary.

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

Check the device or its packaging for

GTIN 00810087180126, Serial Numbers: 102174748, 103355157, 103432386, 103480452, 103547915, 103836571, 1-215-0040, 1-226-0123, 1-227-0129, 1-228-0139, 1-22C-0216, 1-234-0276, 1-237-0307, 104015648, 104993721, 1-233-0266, 1-236-0305, 1-237-0307.

Why: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Distributed: International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
Company: Boston Scientific Corporation
Announced: 29 July 2026This is the date the recall was announced. A company may have started it weeks earlier.
Recall began: 11 June 2026

Source: FDA record Z-2750-2026 · retrieved 17 July 2026

Read the official notice

Every recall is shown word for word from the FDA and USDA, with a link to the source.