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Use caution Medical device recall · FDA · Published April 26, 2020

Argon Medical Skater Introducer Set 6F 18cm: Tungsten Coils May Detach

Argon Medical recalls Skater Introducer Set 6F x 18cm due to risk of tungsten coils detaching from guidewires during use in non-vascular procedures.

🇺🇸 FDA recall #Z-2109-2020Medical deviceArgon Medical ›
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Recalling firmArgon Medical Devices, Inc1445 Flat Creek Rd · Athens, TX 75751-5002
✎ GovInfoNow plain-language explainer

What happened, in plain English

Argon Medical is recalling Skater Introducer Set 6F x 18cm kits because tungsten coils can detach from the guidewire. This could cause the guidewire to become stuck or dislodged during medical procedures, potentially leading to complications. Read more at govinfonow.com/recall/65290-argon-medical-skater-introducer-set-6f-18cm-tungsten-coils-may.

Source Summary by GovInfoNow · govinfonow.com/recall/65290-argon-medical-skater-introducer-set-6f-18cm-tungsten-coils-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2109-2020

Cite this page

“Argon Medical Skater Introducer Set 6F 18cm: Tungsten Coils May Detach.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65290-argon-medical-skater-introducer-set-6f-18cm-tungsten-coils-may. Based on FDA recall #Z-2109-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2109-2020%22&limit=1).

Why it’s dangerous

The tungsten coils in the guidewire can detach during use, which may cause the guidewire to become stuck or dislodged. This could lead to complications such as tissue damage or the need for additional procedures.

Who’s affected

Medical professionals using the Skater Introducer System for non-vascular procedures are most at risk. Patients undergoing such procedures may be affected if the device is used without the recall fix.

How to tell if you have this one

Check for the product code 651506300/(01)00886333005000 or 655506300/(01)00886333005079 on the packaging. The Skater Introducer System is used for fine needle puncture and tissue dilation in non-vascular procedures.

  • Brand
    Argon Medical
  • Product
    Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000; 655506300/(01)00886333005079
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Codes

    Look for the product codes 651506300/(01)00886333005000 or 655506300/(01)00886333005079 on the packaging.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

1. Firm started the recall: Apr 26, 202012. FDA classified it Class II: May 22, 202023. Published in FDA’s Enforcement Report: Jun 3, 202034. FDA terminated the recall: Dec 16, 2022420202022
  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-2109-2020 (April 26, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2109-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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