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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
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Classification
Class II
Status
Ongoing
Distribution / sold at
International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
Recall initiated
2026-06-11
Code info
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.
Product quantity
18 units
Voluntary mandated
Voluntary: Firm initiated
City
Saint Paul
State
MN
Country
United States
Event id
99230
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