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U.S. Department of Health and Human Services

Class 2 Device Recall Option Elite Retrievable Vena Cava Filter

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  Class 2 Device Recall Option Elite Retrievable Vena Cava Filter see related information
Date Initiated by Firm June 08, 2023
Date Posted July 27, 2023
Recall Status1 Open3, Classified
Recall Number Z-2239-2023
Recall Event ID 92585
510(K)Number K133243  
Product Classification Filter, intravascular, cardiovascular - Product Code DTK
Product Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Filter, Suitable of Jugular or Femoral Delivery, STERILEO, RxOnly, CE 2797
Code Information Lot: 11481383, UDI: (00)886333217151
Recalling Firm/
Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information Contact Scott Bishop
Manufacturer Reason
for Recall
There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
FDA Determined
Cause 2
Under Investigation by firm
Quantity in Commerce 3.0
Distribution US Nationwide distribution in the state of TX.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DTK and Original Applicant = REX MEDICAL LP