Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FARAWAVE 1.0 Pulsed Field Ablation Catheter Recalled by Boston Scientific Corporation Due to The potentially impacted units were manufactured using specific...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.
Affected Products
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Quantity: 445 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report