Boston Scientific recalls FARASTAR PFA generators with Product ID 61M401 that may not work with FARAPOINT catheters. Affected units include specific serial numbers and model.
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
Boston Scientific is recalling specific FARASTAR Ablation Generators (Product ID 61M401) because they are incompatible with FARAPOINT PFA catheters. This could lead to improper treatment during cardiac procedures.
The recalled generators have a configuration that does not match the FARAPOINT catheter's requirements. This incompatibility could cause improper treatment during cardiac procedures, potentially leading to ineffective therapy or complications.
Healthcare providers using the FARASTAR generator with FARAPOINT catheters for percutaneous cardiac ablation procedures. Patients undergoing these procedures with the recalled devices are at risk.
Check for Product ID 61M401 on the generator. Affected units have specific serial numbers: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.
Look for the serial numbers listed: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.
Boston Scientific is recalling specific FARASTAR Ablation Generators (Product ID 61M401) because they are incompatible with FARAPOINT PFA catheters.
Check the serial number against the list: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172. If it matches, contact Boston Scientific for guidance.
The recall record does not mention a remedy or fix. Affected units may need to be replaced or adjusted by a healthcare provider.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2753-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2753-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
