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ALN 2in1

A.L.N. · Model RK-2010 · UDI-DI 03760017680127

DTK

510(k) clearances

38,385

Adverse events (930 deaths)

Recalls

Facilities

Description

The device is a 2in1 Extraction Kit of ALN Vena Cava Filter including a puncture needle, a J guidewire, a 9F introduction sheath, a dilatator and a pincer catheter 7F.

Recalls

Date	Firm	Reason
2025-09-12	Argon Medical Devices, Inc	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 int
2023-06-08	Argon Medical Devices, Inc	There is the potential that the vena Cava Filter may not perform as intended which may result in pulmonary embolism.
2022-02-14	Cook Medical Incorporated	IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
2022-02-14	Cook Medical Incorporated	IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
2019-02-25	Cook Medical Incorporated	Updates to the Instructions for Use.
2019-02-25	Cook Medical Incorporated	Updates to the Instructions for Use.
2019-02-25	Cook Medical Incorporated	Updates to the Instructions for Use.
2019-02-25	Cook Medical Incorporated	Updates to the Instructions for Use.
2019-02-25	Cook Medical Incorporated	Updates to the Instructions for Use.
2019-02-25	Cook Medical Incorporated	Updates to the Instructions for Use.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.