Boston Scientific Corporation: Medical Device Recall in 2025 - (Recall #: Z-2278-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401

Product Classification:

Class II

Date Initiated: June 25, 2025

Date Posted: August 20, 2025

Recall Number: Z-2278-2025

Event ID: 97207

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.

Status: Ongoing

Product Quantity: 445 units

Code Information:

UDI-DI: 00191506043148; Batch Numbers: 36543581 36543644 36543646 36568553 36572565 36572568 36572571 36572576 36578308 36578314 36579110 36598352 36598809 36599402 36600406 36600543 36600544 36600545 36600578

Distribution Pattern:

US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated