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U.S. Department of Health and Human Services

Class 2 Device Recall FARAWAVE 1.0 Pulsed Field Ablation Catheter

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 Class 2 Device Recall FARAWAVE 1.0 Pulsed Field Ablation Cathetersee related information
Date Initiated by FirmJune 25, 2025
Date PostedAugust 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2278-2025
Recall Event ID 97207
PMA NumberP230030 
Product Classification Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation - Product Code QZI
ProductFARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Code Information UDI-DI: 00191506043148; Batch Numbers: 36543581 36543644 36543646 36568553 36572565 36572568 36572571 36572576 36578308 36578314 36579110 36598352 36598809 36599402 36600406 36600543 36600544 36600545 36600578
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		The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionAn Urgent Medical Device Removal - Immediate Action Required notification letter dated June 2025 was sent to customers. Actions 1. Do NOT use affected product (Attachment 1), remove affected devices from your facility s inventory, segregate the units in a secure place until they can be returned to Boston Scientific. 2. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization for awareness and to any organization where affected devices have been transferred. 4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions on page five. 5. Return affected product. Email: BSCFieldActionCenter@bsci.com Reach out to your local Boston Scientific representative with any questions.
Quantity in Commerce445 units
DistributionUS Nationwide.
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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