FDA-Device2025-12-03Class IIPROCESSING DEFECT
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 t
Hazard
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
Intended for
Adults
Illnesses reported
None reported
Sold states
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
Affected count
Total devices 1821 (US=1794 and O.U.S.=27) units
Manufactured in
1445 Flat Creek Rd, N/A, Athens, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0589-2026More Argon Medical Devices recalls
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