# FDA recall Z-2755-2017

> **Medtronic Navigation, Inc.** · Class II · device recall initiated 2017-06-07.

## Product

Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing Set, (1) Drainage Bag.  Medtronic Navigation, Inc. Louisville, CO  80027

## Reason for recall

Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around the optical fiber to ensure adequate saline flow through the cooling system. When the TBA is unable to seal around the optical fiber, low retention force to the optical fiber may occur, causing saline to leak out of the TBA.

## Distribution

US Distribution to the states of : CA, GA, MN, FL, NY, IL, TX

## Key facts

- **Recall number:** Z-2755-2017
- **Recalling firm:** Medtronic Navigation, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-07
- **Report date:** 2017-08-02
- **Termination date:** 2018-06-29

- **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-2755-2017

## Citation

> AI Analytics. FDA recall Z-2755-2017. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2755-2017. Source: US FDA. Licensed CC0.

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