# FDA recall Z-0025-2018

> **Medtronic Navigation, Inc.** · Class II · device recall initiated 2017-07-27.

## Product

VCLAS (Visualase Cooled Laser Ablation System)   Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip;  Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip;  Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip

## Reason for recall

The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process.

## Distribution

US nationwide distribution.

## Key facts

- **Recall number:** Z-0025-2018
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-07-27
- **Report date:** 2017-10-25
- **Termination date:** 2019-08-05

- **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-0025-2018

## Citation

> AI Analytics. FDA recall Z-0025-2018. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0025-2018. Source: US FDA. Licensed CC0.

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