# FDA recall Z-3251-2018

> **Medtronic Navigation, Inc.** · Class II · device recall initiated 2018-06-01.

## Product

Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542

## Reason for recall

Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue.

## Distribution

U.S.: MN, NY, PA, FL, AZ, MA, VA, CA, CO, AL, WI, TX, MO, DC, OH, NH, GA, SC, NJ, WA, CT, MI, OK, IN, MD, IL, KY, LA, OR, RI, UT, AR, MS, TN, NC    Foreign: United Kingdom, Germany, Switzerland, Netherlands, Israel

## Key facts

- **Recall number:** Z-3251-2018
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-01
- **Report date:** 2018-10-03
- **Termination date:** 2022-02-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3251-2018

## Citation

> AI Analytics. FDA recall Z-3251-2018. Retrieved 2026-08-02 from https://api.ai-analytics.org/recall/Z-3251-2018. Source: US FDA. Licensed CC0.

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