Medtronic Navigation, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1905-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 8, 2019

Date Posted: May 13, 2020

Recall Number: Z-1905-2020

Event ID: 85354

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.

Status: Terminated

Product Quantity: 4654 units

Code Information:

All kits with lot numbers from 0211041602 through 0217695790

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated