WhichRecall
Class IIReported 2025-12-03

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

Recalled by Argon Medical Devices, Inc

Reason for Recall

Due to complaints of increased resistance when advancing the dilator within the introducer sheath

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This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied

Recall Number
Z-0589-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-09-12
Reported
2025-12-03
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
Code Info
Model Number: 352506070E UDI-DI code: 00886333217151 Lot Numbers: 11633166 11633125 11629543 11629273 11628836
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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