Scorpion recallZ-2501-2021 · Argon Medical Devices, Inc · initiated Jul 8, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Argon Medical Devices, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2501-2021
- Status
- Open, Classified
- Initiated by the company
- Jul 8, 2021
- Recalling firm
- Argon Medical Devices, Inc
- Quantity
- 20 units
- Product code
- DYB
- FDA submissions
- K202141
- Distribution
- U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
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.
Code information (models, lots, serial numbers)
Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Scorpion TPS005Argon Medical Devices, Inc. · Introducer, Catheter1 recall2 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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