Medtronic Navigation, Inc. recalls Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are package…

Recall date

September 1, 2016

Source

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

Recall number

Z-0323-2017

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.

Sold / distributed

Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia.

Why it was recalled

Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging system it pulls and/or bends toward the field.

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

What was recalled

Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The visualization stylet is constructed of titanium and used during Visualase laser ablation procedures by inserting it into intracorporeal catheter lumens for improved catheter stiffness and MRI visualization during procedures.