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 number

Z-2501-2021

Recalling firm

Argon Medical Devices, Inc

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.

Status

Open, Classified

Initiated

2021-07-08

Posted

not on file

Terminated

not on file

Reason

As a result of design changes, sheaths have exhibited cracking/breaking at the tips.

Root cause

Device Design

Action

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.

Quantity

20 units

Distribution

U.S. Nationwide distribution in the state of WA. O.U.S.: N/A

Lot, serial or model codes

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

510(k) numbers

["K202141"]

PMA numbers

not on file

Product code

DYB

Firm FEI

1625425

Firm city

Athens

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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