Urgent Medical Device Recall of Limited Number of FARAWAVE™ Pulsed Field Ablation Catheters in the United States Only

Boston Scientific has identified a specific manufacturing issue impacting certain lots comprising approximately 500 total units of the first generation FARAWAVE™ Pulsed Field Ablation Catheter. These lots were built between May 19 and May 26 of this year (2025) and distributed in the United States only. A subset of devices are potentially affected.

Boston Scientific has already initiated direct communication to approximately 140 centers that have received lots that may contain affected devices (LOT numbers listed below).

The manufacturing issue has the potential to lead to cracks in the electrode bands on the catheter’s distal end. If an electrode band cracks, there is a theoretical risk that the band may become loose and/or detached from the catheter spline during catheter deployment, ablation, or general manipulation of the device, and possibly lead to an embolism. A cracked electrode band may also result in a sharp edge, that could lead to tissue trauma. Neither of these theoretical possibilities has been observed in the field. Boston Scientific has not received any complaints nor reports of patient harm relating to this issue. The manufacturing process has been corrected, and currently built products are not susceptible to this issue.