# FDA recall Z-0244-2023

> **Medtronic Navigation, Inc.** · Class II · device recall initiated 2022-10-14.

## Product

Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE  FIBER 10MM TIP product.  Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.

## Reason for recall

Due to a defect in the outer pouch sterile seal

## Distribution

U.S. Nationwide distribution including in the states AZ, CA, CO, DC, FL, IL, KY, MA, MD, ME, MI, MN, MO, NH, NJ, NY, OH, PA, RI, TX, VA, WA, and WV.

## Key facts

- **Recall number:** Z-0244-2023
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-10-14
- **Report date:** 2022-11-23

- **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-0244-2023

## Citation

> AI Analytics. FDA recall Z-0244-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0244-2023. Source: US FDA. Licensed CC0.

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