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.
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
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.
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.
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.
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.
Identify the item number (TPS005 for stylet or TPS006 for needle) and lot number (11369609) to confirm if your device is affected.
The sheaths in the Scorpion Portal Vein Access Set can crack or break at the tips due to design changes, which could lead to device failure during use.
The recall does not specify a remedy, so check the item numbers and lot number to determine if your device is affected.
The recall states sheaths can crack or break at the tips, which could lead to complications during liver vein procedures, but no specific injury risk is described.
We’ve drafted a message you can send Argon Medical Devices to request your refund or repair — edit it as you like.
Subject: Recall Z-2501-2021 — Argon Medical Devices Argon Medical Devices Hello, I own a Argon Medical Devices that is covered by recall Z-2501-2021 from Argon Medical Devices. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
