Argon Medical Devices, Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Argon Medical Devices, Inc
Lot Codes / Batch Numbers
Item Numbers: TPS005 (Stylet), TPS006 (Needle), UDI Code: 00886333225552 Lot Number: 11369609
Products Sold
Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609
Argon Medical Devices, Inc is recalling Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a due to As a result of design changes, sheaths have exhibited cracking/breaking at the tips.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Recommended Action
Per FDA guidance
On 07/08/2021, the firm's sales representative/clinical Specialist contacted via telephone to inform the single customer that the Recalling Firm was pausing evaluations of the affected device and was requesting return of the device. The customer was also informed that the Recalling Firm was in the process of implementing a few changes to improve upon the product. The product was place on hold at the customer's facility and the Recalling Firm's sales representative was picked up and returned to the Recalling Firm on 07/21/2021.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026