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U.S. Department of Health and Human Services

Class 2 Device Recall FARASTAR

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 Class 2 Device Recall FARASTARsee related information
Date Initiated by FirmJune 11, 2026
Date PostedJuly 17, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2750-2026
Recall Event ID 99230
PMA NumberP230030 P230030S012 
Product Classification Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation - Product Code QZI
ProductFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Code Information 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.
FEI Number 2124215
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
4100 Hamline Ave N
Saint Paul MN 55112-5700
For Additional Information ContactClara Johnson
763-494-1133
Manufacturer Reason
for Recall		Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
FDA Determined
Cause 2		Under Investigation by firm
ActionBoston Scientific issued an Urgent Field Safety Notice - Urgent Medical Device Correction notice to its consignees out side the US on 6/11/2026 via hand delivered letter. The notice explained the issue and requested the following actions be taken: Instructions: 1- Post a copy of the appropriate IFU provided near each FARASTAR PFA generator, replacing any previous versions currently in use. 2- Review the IFU and ensure all relevant personnel are aware of its contents. 3- Please complete the attached Acknowledgement Form even if you do not have any affected product and return it to your Boston Scientific office. 4- Share this communication with any healthcare professionals in your facility that use the product and with any other organization to which this product may have been transferred. The national Competent Authority was informed of this communication. Any adverse events or quality concerns associated with use of these devices should be reported to Boston Scientific and Competent Authorities if appropriate.
Quantity in Commerce18 units
DistributionInternational distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = QZI
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