Class 2 Device Recall Option"ELITE Vena Cava Filter System

• Date Initiated by Firm: September 12, 2025
• Date Posted: November 24, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0589-2026
• Recall Event ID: 97626
• 510(K)Number: K133243
• Product Classification: Filter, intravascular, cardiovascular - Product Code DTK
• Product: Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions: " Pulmonary thromboembolism when anticoagulants are contraindicated " Failure of anticoagulant therapy in thromboembolic disease " Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced " Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated
• Code Information: Model Number: 352506070E UDI-DI code: 00886333217151 Lot Numbers: 11633166 11633125 11629543 11629273 11628836
• 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: Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied
• FDA Determined Cause: Equipment maintenance
• Action: On 09/12/2025, the firm sent via certified mail an "Urgent - Product Recall Notice" to customers. On 9/2025 the firm sent a follow-up "URGENT - MEDICAL DEVICE RECALL NOTICE" dated 9/29/2025 informing them that Argon Medical Devices is voluntarily recalling five affected lots of the Option ELITE Vena Cava Filter System products in response to reports of increased resistance when advancing the dilator within the introducer sheath. Customers are instructed to: 1. Immediately discontinue use of the affected devices listed in the Recall Letter. 2. Segregate and quarantine the affected devices. 3. Complete and return the response form included at the end of this notification via regular mail or email by 9/26/2025. 4. Return all affected devices to Argon Medical Devices using the instructions provided below. 5. Share this recall notice with the following parties to ensure consignees receive a copy and respond accordingly: a. Anyone within their organization who may use this device. b. Any organization where the potentially affected products have been transferred or further distributed. c. Anyone who needs to be aware within their organization. The product may be returned at Argon s expense to the address below with the returned goods authorization (RGA# 29074) clearly marked. RGA# 29074 Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 USA For any questions contact/email Clayton.Jones@argonmedical.com, or Scott.Bishop@argonmedical.com.
• Quantity in Commerce: Total devices 1821 (US=1794 and O.U.S.=27) units
• Distribution: U.S. (nationwide) distribution to states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. O.U.S. (international) to countries of: China, Panama and Trinidad and Tobago
• 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