Visualase Visualization Stylets PN 020-2301 — Class II medical device recall Z-0322-2017
Terminated recall by Medtronic Navigation, Inc., reported 2016-11-09, distributed in CA, FL, GA, TX. Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visu
| Recall number | Z-0322-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2016-09-01 |
| Classified | 2016-10-28 |
| Reported by FDA | 2016-11-09 |
| Terminated | 2017-03-27 |
| Distributed | CA, FL, GA, TX |
| Countries outside the US | AU |
| Quantity | 100 units |
| Lot numbers | 151481 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0322-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.