Argon Medical Scorpion Portal Vein Access Set: Sheath Cracking Risk
Argon Medical recalls Scorpion Portal Vein Access Sets with sheaths that crack at tips, posing a risk of injury during liver vein procedures. Affected items include specific stylets and needles sold with lot number 11369609.
Use caution until it’s fixed
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Contact the company
What happened, in plain English
Argon Medical is recalling Scorpion Portal Vein Access Sets because the sheaths can crack at the tips during use. This could lead to complications if the device fails while accessing the hepatic vein for medical procedures. Read more at govinfonow.com/recall/62231-argon-medical-scorpion-portal-vein-access-set-sheath-cracking-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/62231-argon-medical-scorpion-portal-vein-access-set-sheath-cracking-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2501-2021
Cite this page
“Argon Medical Scorpion Portal Vein Access Set: Sheath Cracking Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/62231-argon-medical-scorpion-portal-vein-access-set-sheath-cracking-risk. Based on FDA recall #Z-2501-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2501-2021%22&limit=1).
Why it’s dangerous
The sheaths in the Sc:orpion Portal Vein Access Set can crack or break at the tips due to design changes. This could cause the device to fail during use, potentially leading to complications when accessing the hepatic vein for medical procedures.
Who’s affected
Healthcare professionals using the Scorpion Portal Vein Access Set for liver vein procedures are most at risk. Patients undergoing these procedures may also be affected if the device cracks during use.
How to tell if you have this one
Check for the item numbers TPS005 (Stylet) or TPS006 (Needle) with lot number 11369609. The product is used to access the hepatic vein and guide puncture tools through liver tissue.
- Brand
Argon Medical Devices- Category
Medical device
What to do — step by step
Check Device Details
Identify the item number (TPS005 for stylet or TPS006 for needle) and lot number (11369609) to confirm if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “U.S. Nationwide distribution in the state of WA. O.U.S.: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 3 months 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-2501-2021 (July 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2501-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.