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.
Enforcement
- Recall Number
- Z-0323-2017
- Event ID
- 75124
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Navigation, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 9, 2016
- Initiation Date
- September 1, 2016
- Classification Date
- October 28, 2016
- Termination Date
- March 27, 2017
- Address
- 826 Coal Creek Cir, Louisville, CO, 80027-9710, United States
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.
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.
Lot number 151591
Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia.
100 total units