Boston Scientific Corporation: FARAWAVE 1.0 Pulsed Field Ablation Catheter, Product ID M004PF41M401

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.

Details from the source

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. Distribution: US Nationwide. Quantity: 445 units Lot/code info: UDI-DI: 00191506043148; Batch Numbers: 36543581 36543644 36543646 36568553 36572565 36572568 36572571 36572576 36578308 36578314 36579110 36598352 36598809 36599402 36600406 36600543 36600544 36600545 36600578

UPC codes

00191506043148

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.