The Recall Desk
HighFDA (Devices)·Z-2501-2021·Announced 2021-09-29

Scorpion Portal Vein Access Set Recalled for Cracking Sheaths

Argon Medical Devices is recalling the Scorpion Portal Vein Access Set due to design changes that have caused the sheaths to crack or break at the tips. The affected product was distributed in the United States.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device with a structural defect (sheaths cracking or breaking at the tips) occurring in a high-risk product used during invasive hepatic procedures. Although no injuries have been reported, the defect represents a genuine risk of harm where injury has not yet been reported.

Plain-English summary

Argon Medical Devices, Inc. is recalling the Scorpion Portal Vein Access Set (Item Numbers TPS005 and TPS006, Lot Number 11369609) because design changes have resulted in the sheaths cracking or breaking at the tips.

The Scorpion Portal Vein Access Set is used during hepatic interventional procedures to access the hepatic vein and guide a sharp puncture instrument through liver tissue. Cracking or breaking sheaths during use could result in unintended tissue damage or compromise the safety of the procedure.

The recalled product was distributed in the United States. The recall involves 20 units.

Healthcare facilities that have received this product should immediately discontinue use and contact Argon Medical Devices, Inc. for instructions on return or disposal of the affected units.

The recalled product

Product
Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool (0.040 Stylet or 17ga Needle) through the parenchyma.
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Vascular Access Device
Hazard
  • sheath-cracking
  • structural-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Item Numbers: TPS005 (Stylet)
  • TPS006 (Needle)
  • UDI Code: 00886333225552 Lot Number: 11369609

Distribution

Distributed nationwide across the United States.

Related recalls

Same category