Boston Scientific recalls FARASTAR PFA Generator (Product ID M004PFCE61M460) due to missing FARAPOINT PFA catheter information in instructions. Affected units have specific serial numbers and GTIN.
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 because the instructions for use did not include information about the FARAPOINT PFA catheter. This labeling issue could lead to incorrect use of the device.
The device was distributed with instructions that did not include the FARAPOINT PFA catheter information. This labeling discrepancy could lead to incorrect use of the device during cardiac ablation procedures.
Medical professionals who own or use the FARASTAR PFA Generator with the listed serial numbers are affected. Patients using this device with the specific model are at low risk due to the labeling discrepancy.
Check for the FARASTAR PFA Generator with Product ID M004PFCE61M460. Affected units have specific serial numbers listed in the recall notice: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816.
Look for the Product ID M004PFCE61M460 and the listed serial numbers on the device.
The FARASTAR PFA Generator with Product ID M004PFCE61M460.
The recall notice does not specify a remedy, so check with Boston Scientific for further instructions.
Check for the Product ID M004PFCE61M460 and the specific serial numbers listed in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2752-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2752-2026 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.
