FDA-Device2026-07-29Class IIMISBRANDING
Boston Scientific FARASTAR Ablation Generator recalled for incomplete instructions
LABEL MIX UPNationwide distribution
Boston Scientific FARASTAR ablation generator recalled for incomplete instructions
Boston Scientific distributed 18 FARASTAR Ablation Generator units in Europe with incomplete Instructions For Use (IFU). The labeling did not include information about the FARAPOINT PFA catheter, which is used with the device. This discrepancy could affect proper device setup and use.
- If you operate or maintain one of the affected units, contact Boston Scientific immediately for corrected instructions
- Do not discard the device; follow Boston Scientific's guidance on obtaining complete labeling
Hazard
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Sold states
International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
Affected count
18 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-2750-2026More 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 PFA Generator recalled for catheter incompatibility
- 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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