Boston Scientific FARASTAR Ablation Generator EU Recall: Incompatible with FARAPOINT
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.
Lower-risk recall
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter.
What happened, in plain English
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. Read more at govinfonow.com/recall/127776-boston-scientific-farastar-ablation-generator-eu-recall-incompatible-with-farapoint.
Source Summary by GovInfoNow · govinfonow.com/recall/127776-boston-scientific-farastar-ablation-generator-eu-recall-incompatible-with-farapoint · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2753-2026
Cite this page
“Boston Scientific FARASTAR Ablation Generator EU Recall: Incompatible with FARAPOINT.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/127776-boston-scientific-farastar-ablation-generator-eu-recall-incompatible-with-farapoint. Based on FDA recall #Z-2753-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2753-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Boston Scientific- Category
Medical device
What to do — step by step
Check Generator Serial Number
Look for the serial numbers listed: 1-217-0053, 1-21C-0078, 1-223-0099, 1-225-0106, 1-225-0107, 1-229-0172.
How this recall unfolded
Recall timeline
FDA published this recall 48 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-2753-2026 (June 11, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2753-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.