Recall Z-2751-2026— Boston Scientific Corporation

Name: FDA recall Z-2751-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-11

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2026-06-11. FDA's recall record names no specific 510(k) clearance for this event. Product: FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter. Reason: Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-06-11
Firm location: Saint Paul, MN, United States

Product description

FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter

Reason for recall

Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.

Data sourced from openFDA. This site is unofficial and independent of the FDA.