Recall Z-0322-2017— Medtronic Navigation, Inc.

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2016-09-01, terminated 2017-03-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Visualase Visualization Stylets PN 020-2301. 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. Reason: 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..

Recalling firm

Medtronic Navigation, Inc.

Classification

Class II

Status

Terminated

Initiated

2016-09-01

Terminated

2017-03-27

Firm location

Louisville, CO, United States

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