Boston Scientific recalls FARASTAR Pulsed Field Ablation Generator with labeling discrepancy affecting FARAPOINT PFA catheter use. No immediate action needed but check product details.
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information.
Boston Scientific is recalling a specific model of cardiac ablation generator due to missing instructions for a related catheter. This labeling error means users might not know how to safely use the catheter, but it does not cause immediate harm.
The device was distributed without instructions for the FARAPOINT PFA catheter. This labeling discrepancy could lead to improper use if the catheter is not correctly integrated into the procedure, but it does not cause immediate injury.
Patients undergoing cardiac ablation procedures who use the recalled generator. Medical professionals handling the device may also be affected if they rely on the missing instructions.
Check for the product ID M004PFCE61M401 on the generator. The serial number 106247020 is also associated with this specific recall.
Review the generator's product ID and serial number to confirm if it matches the recalled items.
No immediate danger is reported. The labeling issue does not cause injury but may affect proper use of the catheter.
No. The recall does not require stopping use; it only addresses missing instructions for the catheter.
Look for the product ID M004PFCE61M401 and serial number 106247020 on the generator.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2751-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2751-2026 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.
