Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 Recalled by Argon Medical Devices, Inc Due to Due to complaints of increased resistance when advancing...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Argon Medical Devices, Inc directly.
Affected 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
Quantity: Total devices 1821 (US=1794 and O.U.S.=27) units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Argon Medical Devices, Inc
Argon Medical Devices, Inc has 42 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report