Medtronic Navigation, Inc.: 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.

Agency Publication Date: October 28, 2016

Affected Products

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

Lot number 151481

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Product: 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.

Lot number 151591

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 75124

Status: Resolved

Manufacturer: Medtronic Navigation, Inc.

Manufactured In: United States

Units Affected: 2 products (100 total units)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot number 151481

Lot Numbers:

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Lot number 151591

Lot Numbers:

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