FARASTAR Ablation Generator and Cardiac Ablation Catheter
Boston Scientific is recalling FARASTAR Ablation Generators and Cardiac Ablation Catheters due to missing information in the device labeling.
Review the updated Instructions For Use (IFU) provided by the manufacturer and contact Boston Scientific for further guidance regarding the missing catheter information.
Why it was recalled
Boston Scientific is recalling the FARASTAR Ablation Generator and associated Percutaneous Cardiac Ablation Catheter due to a labeling discrepancy. The provided Instructions For Use (IFU) for these devices failed to include necessary information regarding the FARAPOINT PFA catheter.
Is mine affected?
This recall covers the products below. If you have any of them, yours is affected.
| Product |
|---|
| FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter |
| FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter |
| FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter |
Official source
Other recent recalls from Boston Scientific Corporation
Editorial summary by Recall Canary · last updated 2026-07-20 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification