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Lower risk Medical device recall · FDA · Published June 11, 2026

Boston Scientific FARASTAR Ablation Generator EU Recall: Labeling Issue

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2750-2026Medical deviceBoston Scientific ›
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/127778-boston-scientific-farastar-ablation-generator-eu-recall-labeling-issue.

Source Summary by GovInfoNow · govinfonow.com/recall/127778-boston-scientific-farastar-ablation-generator-eu-recall-labeling-issue · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2750-2026

Cite this page

“Boston Scientific FARASTAR Ablation Generator EU Recall: Labeling Issue.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/127778-boston-scientific-farastar-ablation-generator-eu-recall-labeling-issue. Based on FDA recall #Z-2750-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2750-2026%22&limit=1).

The FDA announced on June 11, 2026, that Boston Scientific Corporation voluntarily recalled FARASTAR Ablation Generator EU devices due to a labeling discrepancy. The hazard involves missing catheter information in the Instructions For Use.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator
  • Product ID: 61M401
  • UPC: 00810087180126
  • Serial Numbers: 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

The hazard

According to the FDA, devices were distributed with Instructions For Use that did not include FARAPOINT PFA catheter information.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent brand recalls include the Aug. 24, 2026, Imager II Angiographic Catheters Recall for tip fracture risk and the Aug. 6, 2026, LUX-Dx Cardiac Monitor System Recall for delayed AF burden alerts. Other recent recalls of similar products include the June 17, 2026, Blom-Singer Classic Voice Prosthesis Recall and the June 17, 2026, Freudenberg Medical Blom-Singer Voice Prosthesis Recall, both for incorrect labeling hazards.

How to tell if you have this one

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.

  • Brand
    Boston Scientific
  • Product
    FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation
  • Category
    Medical device
FDA recall event · 3 products

All 3 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    International distribution in the states of Austria, Spain, France, Germany, Denmark, Italy, Portugal, Great Britain, Ireland.
Recall numberProduct, codes & lotsQuantity
Z-2750-2026FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter; GTIN 00810087180126, Serial Numbers: 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, 1-237-0307.18 units
Z-2751-2026FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter; GTIN 00191506042547, Serial Numbers: 106247020.1 units
Z-2752-2026FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter; GTIN 00191506043643, Serial Numbers: 106205893, 106450787, 107392777, 107476023, 108017345, 108521214, 108577158, 108695934, 109072152, 109484718, 109892816.11 units
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Verify if your device has a serial number listed in the recall notice.

How this recall unfolded

Recall timeline

FDA published this recall 48 days after the firm started it.

1. Firm started the recall: Jun 11, 202612. FDA classified it Class II: Jul 17, 202623. Published in FDA’s Enforcement Report: Jul 29, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of injury from this product?

The recall is due to a labeling issue, not an immediate safety hazard. The risk is low as it relates to proper instruction use.

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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-2750-2026 (June 11, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2750-2026 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA