Z-2278-2025Class II

FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401

Name: Z-2278-2025 FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Creator: Boston Scientific Corporation
Published: 2025-06-25
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2025-06-25 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401 on 2025-06-25. FDA classified it as Class II and gives the reason as "The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2278-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-25
Posted: 2025-08-08
Recalling firm: Boston Scientific Corporation
Product: FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401
Product code: QZI Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent Medical Device Removal - Immediate Action Required notification letter dated June 2025 was sent to customers. Actions 1. Do NOT use affected product (Attachment 1), remove affected devices from your facility s inventory, segregate the units in a secure place until they can be returned to Boston Scientific. 2. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization for awareness and to any organization where affected devices have been transferred. 4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions on page five. 5. Return affected product. Email: [email protected] Reach out to your local Boston Scientific representative with any questions.
Quantity in commerce: 445 units
Distribution: US Nationwide.
Product codes and lots: UDI-DI: 00191506043148; Batch Numbers: 36543581 36543644 36543646 36568553 36572565 36572568 36572571 36572576 36578308 36578314 36579110 36598352 36598809 36599402 36600406 36600543 36600544 36600545 36600578

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2278-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2278-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-08

Product code QZI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)