—#216137

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

FDA product code: DTK — Filter, Intravascular, Cardiovascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K133243
Affected lot / code info: Model Number: 352506070E UDI-DI code: 00886333217151 Lot Numbers: 11633166 11633125 11629543 11629273 11628836

Why it was recalled

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

Root cause (FDA determination)

Equipment maintenance

Action the firm took

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.

Recalling firm

Firm: Argon Medical Devices, Inc
Address: 1445 Flat Creek Rd, Athens, Texas 75751-5002

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2025-09-12
Posted by FDA: 2025-11-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216137. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.