Recall Z-0589-2026 ยท DTK Filter, Intravascular, Cardiovascular
Argon Medical Devices, Inc
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 " Emerge
| Date | Nov 24, 2025 (initiated Sep 12, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133243 | OPTION ELITE VENA CAVA FILTER SYSTEM Rex Medical, L.P., Dec 17, 2013 |