Angiodynamics, Inc. recalls AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single…

Recall date

April 24, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0073-2022

FDA classification

Class II

Brand / firm

Angiodynamics, Inc.

Sold / distributed

Internationally distribution to the countries of Australia, Germany, Denmark, France, and Thailand.

Why it was recalled

Programming issue affected RFID function of a single lot and did not allow the NanoKnife probes to be recognized by the NanoKnife generator.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

AngioDynamics NanoKnife Disposable Single Electrode Probes, Irreversible Electroporation (IRE) Device, 15 cm IRE Single Electrode RFID Activation, PG. Catalog No. 20400103