Argon Medical Devices, Inc: Medical Device Recall in 2021 - (Recall #: Z-2501-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 8, 2021

Date Posted: September 29, 2021

Recall Number: Z-2501-2021

Event ID: 88520

Reason for Recall:

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

Status: Ongoing

Product Quantity: 20 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated