FDAFDA · Food and drugs·Recall number Z-2751-2026
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter
Published July 29, 2026 · Recall initiated: June 11, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
- Lot
- GTIN 00191506042547, Serial Numbers: 106247020.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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