FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Summary
The FDA issued a Class II for FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 by Boston Scientific Corporation. Reason: The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal .
Details
Source
Device Recall
External ID
Z-2278-2025
Action Date
2025-08-20
Status
Ongoing
Category
device
Product Description
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Lot/Code Info: UDI-DI: 00191506043148; Batch Numbers: 36543581 36543644 36543646 36568553 36572565 36572568 36572571 36572576 36578308 36578314 36579110 36598352 36598809 36599402 36600406 36600543 36600544 36600545 36600578
Quantity Affected: 445 units
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.
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-06-25
Company
Saint Paul, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 169 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2278-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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