Lower risk Medical device recall · FDA · Published June 25, 2025

Boston Scientific FARAWAVE 1.0 Catheter Recall: Potential Electrode Cracks

Boston Scientific recalls FARAWAVE 1.0 Pulsed Field Ablation Catheters with specific batch numbers due to potential cracks in electrode bands that could affect safety during medical procedures.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2278-2025Medical device Boston Scientific ›

Lower-risk 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.

Take action

Contact the company

Recalling firmBoston Scientific Corporation4100 Hamline Ave N · Saint Paul, MN 55112-5700

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling FARAWAVE 1.0 Pulsed Field Ablation Catheters with certain batch numbers because manufacturing equipment may have caused cracks in the electrode bands. This could lead to improper function during medical procedures if the catheter is used. Read more at govinfonow.com/recall/51964-boston-scientific-farawave-1-0-catheter-recall-potential-electrode-cracks.

Source Summary by GovInfoNow · govinfonow.com/recall/51964-boston-scientific-farawave-1-0-catheter-recall-potential-electrode-cracks · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2278-2025

Cite this page

“Boston Scientific FARAWAVE 1.0 Catheter Recall: Potential Electrode Cracks.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51964-boston-scientific-farawave-1-0-catheter-recall-potential-electrode-cracks. Based on FDA recall #Z-2278-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2278-2025%22&limit=1).

The FDA announced on June 25, 2025, that Boston Scientific Corporation voluntarily recalled FARAWAVE 1.0 Pulsed Field Ablation Catheters due to potential electrode band cracks. The recall affects 445 units distributed nationwide.

How to tell if you have it

Brand: Boston Scientific
Product: FARAWAVE 1.0 Pulsed Field Ablation Catheter
Product ID: M004PF41M401
UDI-DI: 00191506043148
Batch Numbers: 36543581, 36543644, 36543646, 36568553, 36572565, 36572568, 36572571, 36572576, 36578308, 36578314, 36579110, 36598352, 36598809, 36599402, 36600406, 36600543, 36600544, 36600545, 36600578

The hazard

The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Other recent recalls of similar products include B. Braun Medical NES1725KFXL Spinal Epidural Catheter Recall (Jan. 29, 2026) and Argon Medical L-Cath PICC Catheters Recall (June 15, 2026).

How to tell if you have this one

Check for batch numbers: 36543581, 36543644, 36543646, 36568553, 36572565, 36572568, 36572571, 36572576, 36578308, 36578314, 36579110, 36598352, 36598809, 36599402, 36600406, 36600543, 36600544, 36600545, 36600578. The catheter model is FARAWAVE 1.0 Pulsed Field Ablation Catheter.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Batch Numbers
Look for batch numbers listed: 36543581, 36543644, 36543646, 36568553, 36572565, 36572568, 36572571, 36572576, 36578308, 36578314, 36579110, 36598352, 36598809, 36599402, 36600406, 36600543, 36600544, 36600545, 36600578.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 56 days after the firm started it.

Jun 25, 2025Firm started the recall
Aug 8, 2025FDA classified it Class II
Aug 20, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

More Boston Scientific recalls

Link to this recall

<a href="https://govinfonow.com/recall/51964-boston-scientific-farawave-1-0-catheter-recall-potential-electrode-cracks">Boston Scientific FARAWAVE 1.0 Catheter Recall: Potential Electrode Cracks (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2278-2025 (June 25, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2278-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.