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Greenfield™

BOSTON SCIENTIFIC CORPORATION · Model M001504000 · UDI-DI 08714729070276

DTK Prescription

510(k) clearances

38,359

Adverse events (929 deaths)

Recalls

Facilities

Description

Vena Cava Filter

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.