# FDA recall Z-1905-2020

> **Medtronic Navigation, Inc.** · Class II · device recall initiated 2019-07-08.

## Product

Visualase Cooled Laser Applicator System Tubing Set kits    Product numbers:  VCLAS 9735559, 3mm tip/1.65mm catheter  VCLAS 9735560, 10mm tip/1.65mm catheter  VCLAS 9735561, 15mm tip/1.85mm catheter

## Reason for recall

The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion, all of which could result in disruption or prevention of saline flow.

## Distribution

US: AL, AZ, AR, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, ME, MD, MA, MI, MN, MO, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI    OUS: France, Germany, Greece, Iceland, Israel, Spain, Sweden, Switzerland, UK

## Key facts

- **Recall number:** Z-1905-2020
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-07-08
- **Report date:** 2020-05-13
- **Termination date:** 2024-10-16

- **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-1905-2020

## Citation

> AI Analytics. FDA recall Z-1905-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1905-2020. Source: US FDA. Licensed CC0.

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