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

Medical DevicesSource: FDA (device) · Date: 2026-07-29

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Boston Scientific Corporation
Product
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Reason / hazard
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Classification
Class II
Status
Ongoing
Distribution / sold at
International distribution in the countries of Italy, Austria, France, Germany, Belgium.
Recall initiated
2026-06-11
Code info
GTIN/UDI 00810087180126, Serial Numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.
Product quantity
6 units
Voluntary mandated
Voluntary: Firm initiated
City
Saint Paul
State
MN
Country
United States
Event id
99251
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