Food, drugs, devices › Medtronic Navigation, Inc.
Device recall: Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packa
Medtronic Navigation, Inc. (Louisville, CO) initiated this device recall on 1 Sep 2016; FDA lists 2 product records under event 75124, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,232 device enforcement events initiated in 2016 carry the same class.
Status: Terminated, terminated 27 Mar 2017. Initiation: voluntary: firm initiated. Medtronic Navigation, Inc. has 44 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Medtronic Navigation, Inc., Louisville, CO.
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."
Distribution
"Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0322-2017 | 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… | 100 total units | Class II | Terminated | 9 Nov 2016 |
| Z-0323-2017 | 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… | 100 total units | Class II | Terminated | 9 Nov 2016 |
Context
Other enforcement events for Medtronic Navigation, Inc.
All 44 events for Medtronic Navigation, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Mar 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.