Class 2 Device Recall Option Elite Retrievable Vena Cava Filter

• Date Initiated by Firm: June 08, 2023
• Date Posted: July 27, 2023
• Recall Status: Open, 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
• FEI Number: 1625425
• 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: 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