CLASS II ONGOING Device recall · Reported 20 Aug 2025 · FDA Enforcement Report
Farawave 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 recalled
Boston Scientific is recalling Farawave 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401, distributed nationwide in the US. The recall was initiated on 25 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2278-2025
- FDA event ID
- 97207
- Recalling firm
- Boston Scientific, Saint Paul, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Jun 2025
- FDA classified
- 8 Aug 2025
- Reported
- 20 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 25 Jun 2025 | Recall initiated by company | |
| 8 Aug 2025 | Classified by FDA | +44 days |
| 20 Aug 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Where it was distributed
US Nationwide.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI: 00191506043148; Batch Numbers: 36543581 36543644 36543646 36568553 36572565 36572568 36572571 36572576 36578308 36578314 36579110 36598352 36598809 36599402 36600406 36600543 36600544 36600545 36600578
Where was it sold?
US Nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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