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Lower risk Medical device recall · FDA · Published September 22, 2017

Boston Scientific Auriga XL 4007 Laser System Recall: Incorrect Trigger Wire Assembly

Boston Scientific recalls Auriga XL 4007 Laser System with serial numbers 20509715, 20465096, etc. due to incorrect trigger wire assembly causing error codes or console failure during surgery.

🇺🇸 FDA recall #Z-0898-2018Medical deviceBoston Scientific ›
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Recalling firmBoston Scientific Corporation100 Boston Scientific Way · Marlborough, MA 01752-1234
✎ GovInfoNow plain-language explainer

What happened, in plain English

Boston Scientific is recalling certain Auriga XL 4007 Laser Systems that have incorrectly assembled trigger wire components. This could cause the console to show error codes or fail to start during surgical procedures. Read more at govinfonow.com/recall/72953-boston-scientific-auriga-xl-4007-laser-system-recall-incorrect-trigger.

Source Summary by GovInfoNow · govinfonow.com/recall/72953-boston-scientific-auriga-xl-4007-laser-system-recall-incorrect-trigger · Updated September 17, 2026 · FDA enforcement record: FDA #Z-0898-2018

Cite this page

“Boston Scientific Auriga XL 4007 Laser System Recall: Incorrect Trigger Wire Assembly.” GovInfoNow, updated September 17, 2026. https://govinfonow.com/recall/72953-boston-scientific-auriga-xl-4007-laser-system-recall-incorrect-trigger. Based on FDA recall #Z-0898-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0898-2018%22&limit=1).

Why it’s dangerous

The trigger wire, which starts the console, may be assembled incorrectly. This can cause the console to display error codes or not start properly during surgery, potentially disrupting procedures.

Who’s affected

Surgical teams using the Auriga XL 4007 Laser System with the listed serial numbers are affected. The risk is low as the issue only affects console operation, not patient safety directly.

How to tell if you have this one

Check for the serial numbers listed: 20509715, 20465096, 20503137, 20520960, 20541967, 20546219, 20546440, 20575512, and 20575518. The product is a surgical laser system used in medical procedures.

  • Brand
    Boston Scientific
  • Category
    Medical device
FDA recall event · 2 products

All 2 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
    Terminated
  • Distribution
    International Distribution Only -- Australia, Vietnam, France, Germany, Italy, Spain, and Romania.
Recall numberProduct, codes & lotsQuantity
Z-0897-2018Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.; Serial Number: 20413941, 201439442
Z-0898-2018Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.; Serial Number: 20509715, 20465096, 20503137, 20520960, 20541967, 20546219, 20546440, 20575512, and 20575518.9
Based on the official FDA remedy

What to do — step by step

  1. Check Serial Numbers

    Verify if your Auriga XL 4007 Laser System has one of the listed serial numbers: 20509715, 20465096, 20503137, 20520960, 20541967, 20546219, 20546440, 20575512, or 20575518.

How this recall unfolded

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Sep 22, 201712. FDA classified it Class II: Mar 5, 201823. Published in FDA’s Enforcement Report: Mar 14, 201834. FDA terminated the recall: Aug 14, 2018420172018
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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-0898-2018 (September 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0898-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on September 17, 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