{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216137", "product_res_number": "Z-0589-2026", "event_date_initiated": "2025-09-12", "event_date_posted": "2025-11-24", "recall_status": "Open, Classified", "res_event_number": "97626", "product_code": "DTK", "k_numbers": [ "K133243" ], "product_description": "Option\"ELITE Vena Cava Filter System REF 352506070E\nUDI-DI code: 00886333217151\n\nThe 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:\n\" Pulmonary thromboembolism when anticoagulants are contraindicated\n\" Failure of anticoagulant therapy in thromboembolic disease \" Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced\n\" Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated", "code_info": "Model Number: 352506070E\nUDI-DI code: 00886333217151\nLot Numbers:\n11633166\n11633125\n11629543\n11629273\n11628836", "firm_fei_number": "1625425", "recalling_firm": "Argon Medical Devices, Inc", "address_1": "1445 Flat Creek Rd", "city": "Athens", "state": "TX", "postal_code": "75751-5002", "additional_info_contact": "Scott Bishop\n469-430-0546", "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", "root_cause_description": "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.\n\nCustomers are instructed to:\n1. Immediately discontinue use of the affected devices listed in the Recall Letter.\n2. Segregate and quarantine the affected devices.\n3. Complete and return the response form included at the end of this notification via regular mail or email by 9/26/2025.\n4. Return all affected devices to Argon Medical Devices using the instructions provided below.\n5. Share this recall notice with the following parties to ensure consignees receive a copy and respond accordingly:\na. Anyone within their organization who may use this device.\nb. Any organization where the potentially affected products have been transferred or further distributed.\nc. Anyone who needs to be aware within their organization.\n\nThe product may be returned at Argon s expense to the address below with the returned goods authorization (RGA# 29074) clearly marked.\nRGA# 29074\nArgon Medical Devices, Inc.\n1445 Flat Creek Road\nAthens, TX 75751 USA\n\nFor any questions contact/email Clayton.Jones@argonmedical.com, or Scott.Bishop@argonmedical.com.", "product_quantity": "Total devices 1821 (US=1794 and O.U.S.=27) units", "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.\n\nO.U.S. (international) to countries of: China, Panama and Trinidad and Tobago", "openfda": { "k_number": [ "K955396", "K003964", "K901454", "K771046", "K964284", "K121057", "K912144", "K022236", "K241507", "K163699", "K130366", "K932921", "K063217", "K240257", "K172584", "K090140", "K073528", "K140286", "K081138", "K940489", "K161218", "K081410", "K034050", "K760152", "K122585", "K211874", "K052578", "K032426", "K881604", "K242612", "K181202", "K760151", "K152765", "K073374", "K112119", "K061815", "K173236", "K172557", "K133243", "K240578", "K211875", "K912035", "K091077", "K162875", "K963016", "K120402", "K233680", "K023116", "K944353", "K102511", "K970099", "K925679", "K121629", "K171712", "K143208", "K000855", "K010083", "K070514", "K000062", "K031328", "K901235", "K101431", "K043509", "K080668", "K852097", "K093659", "K072240", "K160866", "K143405", "K894703", "K112497", "K050558", "K073090", "K150262", "K963014", "K951508", "K874096", "K113124", "K010485", "K870729", "K082305", "K901659", "K062887" ], "pma_number": [ "P850049" ], "registration_number": [ "3004111573", "3005580113", "1016427", "1820334", "1625425", "2020394", "3002807314", "3007080617", "9612452", "3010383847", "9616099", "3009526575", "3009888344", "1721686", "3007156625", "1643817", "3002808486", "1018233", "3013764800", "3006082230", "1313046", "1722746" ], "fei_number": [ "3004111573", "3005580113", "1000306216", "1016427", "1820334", "1625425", "2020394", "3002807314", "3007080617", "3010383847", "3009526575", "3009888344", "1721686", "1643817", "3002806713", "3003528016", "3002808486", "3008133910", "1018233", "3013764800", "3006082230", "1313046" ], "device_name": "Filter, Intravascular, Cardiovascular", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3375", "device_class": "2" } } ] }