FDA Device recall Z-0322-2017
Visualase Visualization Stylets PN 020-2301
- FDA Device
- Class II
- terminated
- Published 2016-11-09
On 2016-11-09 the FDA classified a Class II recall of Visualase Visualization Stylets PN 020-2301 by Medtronic Navigation, citing medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is pla….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0322-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-01 |
| Published | 2016-11-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Navigation |
| Distribution | CA, FL, GA, TX |
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.
Identifiers
| code_info | Lot number 151481 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0322-2017%22
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