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BioFlo Vortex

Angiodynamics, Inc. · Model H787CT60LTBDVI0 · UDI-DI 15051684017008

LJT Prescription

510(k) clearances

21,942

Adverse events (373 deaths)

141

Recalls

Facilities

Description

SmartPort+ Low Profile Port with Endexo and Vortex Technology

Recalls

Date	Firm	Reason
2026-04-21	ARROW INTERNATIONAL, LLC	Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo
2025-07-21	B.Braun Medical S.A.S.	The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
2025-02-13	Smiths Medical ASD, Inc.	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13	Smiths Medical ASD, Inc.	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13	Smiths Medical ASD, Inc.	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13	Smiths Medical ASD, Inc.	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13	Smiths Medical ASD, Inc.	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13	Smiths Medical ASD, Inc.	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13	Smiths Medical ASD, Inc.	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
2025-02-13	Smiths Medical ASD, Inc.	The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

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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.