# FDA recall Z-2501-2021

> **Argon Medical Devices, Inc** · Class II · device recall initiated 2021-07-08.

## 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.

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-2501-2021
- **Recalling firm:** Argon Medical Devices, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-08
- **Report date:** 2021-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athens, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2501-2021

## Citation

> AI Analytics. FDA recall Z-2501-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2501-2021. Source: US FDA. Licensed CC0.

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