FDA-Device2026-07-29Class IIPROCESSING DEFECT
Boston Scientific FARASTAR PFA Generator recalled for catheter incompatibility
OTHERNationwide distribution
Boston Scientific FARASTAR PFA Generator recalled for incompatibility
Boston Scientific identified specific FARASTAR Pulsed Field Ablation (PFA) generators with a configuration that cannot work safely with the FARAPOINT PFA catheter. Six units with specific serial numbers were distributed across Europe and need to be replaced.
- If you operate or manage a cardiac ablation facility with a FARASTAR PFA generator, check if your serial number matches: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, or 1-229-0172
- Contact Boston Scientific for a replacement generator if your serial number is affected
- Do not use an incompatible FARASTAR generator with the FARAPOINT catheter
Hazard
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Sold states
International distribution in the countries of Italy, Austria, France, Germany, Belgium.
Affected count
6 units
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2753-2026More Boston Scientific Corporation recalls
- FDA-Device2026-07-29Boston Scientific FARADRIVE steerable sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARASTAR Ablation Generator recalled for incomplete instructions
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete instructions
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete labeling
- FDA-Device2026-07-29Boston Scientific TheraSphere 360 Y-90 software anomaly may cause incorrect dose calculations
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