Device 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
Z-0322-2017
Product summary
- Event
- Event 75124
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100 total units
- Official record key
device-enforcement:Z-0322-2017
Official wording
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.
Code information: Lot number 151481
Distribution pattern: Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia.
Derived failure modes
-
Unknown
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.