FDA-Device2026-07-29Class IIPROCESSING DEFECT
Boston Scientific FARASTAR PFA Generator recalled for catheter incompatibility
What this means
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
The agency's original wording
Hazard
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Intended for
Adults
Illnesses reported
None reported
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 recalls
- FDA-Device2026-09-09Boston Scientific LUX-Dx insertable cardiac monitor server software recalled for delayed AF alert notification
- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor system recalled for delayed alert notifications
- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor server software recalled for delayed alert notifications
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
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