Z-2501-2021Class II

Scorpion Portal Vein Access Set -

Name: Z-2501-2021 Scorpion Portal Vein Access Set -
Creator: Argon Medical Devices, Inc
Published: 2021-07-08
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2021-07-08 / Open, Classified / root cause: design

FDA source

Argon Medical Devices, Inc began a recall of 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... on 2021-07-08. FDA classified it as Class II and gives the reason as "As a result of design changes, sheaths have exhibited cracking/breaking at the tips". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2501-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-08
Posted: 2021-09-21
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.
Product code: DYB Introducer, Catheter
Reason for recall: As a result of design changes, sheaths have exhibited cracking/breaking at the tips.
Root cause tag: design
FDA 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 in commerce: 20 units
Distribution: U.S. Nationwide distribution in the state of WA. O.U.S.: N/A
Product codes and lots: Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2501-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2501-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-29	2021-09-21

Product code DYB

K202141Class IIScorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access SetArgon Medical Devices, Inc. / cleared 2021-01-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)