FDA-Device2026-07-29Class IIMISBRANDING
Boston Scientific FARASTAR PFA Generator recalled for incomplete instructions
What this means
Boston Scientific distributed one FARASTAR Pulsed Field Ablation Generator with instructions that were missing information about the FARAPOINT PFA catheter. The incomplete labeling could affect proper device use and patient safety.
- If you received this device, contact Boston Scientific for updated instructions
- Do not use the device until you have complete labeling information
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
1 units
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2751-2026More 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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