Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepatic vein and guide a sharp puncture tool
Summary
The FDA issued a Class II for Scorpion Portal Vein Access Set - Product Usage: used to gain access to the hepa by Argon Medical Devices, Inc. Reason: As a result of design changes, sheaths have exhibited cracking/breaking at the tips..
Details
Source
Device Recall
External ID
Z-2501-2021
Action Date
2021-09-29
Status
Ongoing
Category
device
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.
Lot/Code Info: Item Numbers: TPS005 (Stylet); TPS006 (Needle); UDI Code: 00886333225552 Lot Number: 11369609
Quantity Affected: 20 units
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-08
Company
Athens, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Argon Medical Devices, Inc has 19 FDA actions in our database, including 7 recalls and 12 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Argon Medical Devices, Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Argon Medical Devices, Inc have FDA actions?
Argon Medical Devices, Inc has 19 FDA actions in our database, including 7 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2501-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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