Boston Scientific recalls FARASTAR Ablation Generator EU models due to missing FARAPOINT PFA catheter instructions in product packaging. Consumers should check serial numbers listed in the recall notice.
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Boston Scientific is recalling certain FARASTAR Ablation Generators EU models because the product packaging did not include instructions for the FARAPOINT PFA catheter. This labeling discrepancy could lead to improper use if the catheter is not properly understood by the user.
The devices were distributed without the necessary instructions for the FARAPOINT PFA catheter. This labeling discrepancy means users might not know how to safely use the catheter, potentially leading to improper procedure execution.
Percutaneous cardiac ablation procedures using the FARASTAR Ablation Generator EU models with specific serial numbers. Medical professionals performing these procedures are most at risk.
Check if your FARASTAR Ablation Generator EU has a serial number listed in the recall notice: 102174748, 103355157, 103432386, 103480452, 103547915, 103836571, 1-215-0040, 1-226-0123, 1-227-0129, 1-228-0139, 1-22C-0216, 1-234-0276, 1-237-0307, 104015648, 104993721, 1-233-0266, 1-236-0305, 1-237-0307.
Verify if your device has a serial number listed in the recall notice.
The devices were distributed without instructions for the FARAPOINT PFA catheter, which could lead to improper use.
Check if your device has a serial number listed in the recall notice. If it does, contact Boston Scientific for further instructions.
The recall is due to a labeling issue, not an immediate safety hazard. The risk is low as it relates to proper instruction use.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2750-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2750-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
