FDAHealthJune 11, 2026

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

⚠️ Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.

Is this relevant to me?

Geography: Unknown
Source agency: FDA
Category: Health
Published: June 11, 2026

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

What's affected?

Product: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Brand: Boston Scientific Corporation
Lot code: GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.

Additional details

GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 6 units.

View original FDA notice →

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