Medtronic Navigation, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0323-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 1, 2016

Date Posted: November 9, 2016

Recall Number: Z-0323-2017

Event ID: 75124

Reason for Recall:

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.

Status: Terminated

Product Quantity: 100 total units

Code Information:

Lot number 151591

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated