Reported Aug 20, 2025 · Ongoing
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
FARAWAVE 1.0 Pulsed Field Ablation CatheterProduct ID M004PF41M401
- Lot codes and dates
- UDI-DI00191506043148
- Batch Numbers
36543581365436443654364636568553365725653657256836572571365725763657830836578314365791103659835236598809365994023660040636600543366005443660054536600578
- Amount recalled
- 445 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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