Recall Z-0589-2026— Argon Medical Devices, Inc

Name: FDA recall Z-0589-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-12

Class II · Ongoing

Class II FDA medical device recall by Argon Medical Devices, Inc, initiated 2025-09-12. It names one FDA 510(k) clearance: K133243. 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. 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.

Recalling firm: Argon Medical Devices, Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-09-12
Firm location: Athens, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K133243 — OPTION ELITE VENA CAVA FILTER SYSTEMRex Medical, L.P.·cleared 2013-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.