Reported Dec 3, 2025 · Ongoing
Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated…
Argon Medical Devices, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Argon Medical Devices, Inc · 1445 Flat Creek Rd · Athens, TX · 75751-5002
Is this the product you have?
- Option"ELITE Vena Cava Filter
- System REF 352506070E UDI-DI code00886333217151 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
- Lot codes and dates
- Model Number352506070E
- UDI-DI code00886333217151
- Lot Numbers11633166 11633125 11629543 11629273 11628836
- Amount recalled
- Total devices 1821 (US=1794 and O.U.S.=27) units
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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