Argon Medical recalls Skater Introducer Set 6F x 18cm due to risk of tungsten coils detaching from guidewires during use in non-vascular procedures.
Tungsten coils of the guidewire included in the introducer kit were detaching.
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.
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.
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.
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.
Look for the product codes 651506300/(01)00886333005000 or 655506300/(01)00886333005079 on the packaging.
The tungsten coils in the guidewire can detach during use, which may cause the guidewire to become stuck or dislodged during medical procedures.
Check the product codes on the packaging. If you have the recalled product, contact Argon Medical for instructions.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send Argon Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2109-2020 — Argon Medical Argon Medical Hello, I own a Argon Medical that is covered by recall Z-2109-2020 from Argon Medical. 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.
