FDA-Device2026-07-29Class IIMISBRANDING
Boston Scientific FARASTAR Ablation Generator recalled for incomplete instructions
What this means
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
The agency's original wording
Hazard
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Intended for
Adults
Illnesses reported
None reported
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 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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