Scorpion Portal Vein Access Set — Class II medical device recall Z-2501-2021
Ongoing recall by Argon Medical Devices, Inc, reported 2021-09-29, distributed nationwide. As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
| Recall number | Z-2501-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Argon Medical Devices, Inc, Athens, TX, United States |
| Recall initiated | 2021-07-08 |
| Classified | 2021-09-21 |
| Reported by FDA | 2021-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 20 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00886333225552 |
| Lot numbers | 11369609 |
| Model numbers | TPS005 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2501-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.