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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/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information Contact Scott Bishop
469-430-0546
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
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