Recall Z-1905-2020— Medtronic Navigation, Inc.

Name: FDA recall Z-1905-2020
Creator: U.S. Food and Drug Administration
Published: 2019-07-08

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2019-07-08, terminated 2024-10-16. It names one FDA 510(k) clearance: K071328. 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: 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..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-07-08
Terminated: 2024-10-16
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K071328 — VISUALASE THERMAL THERAPY SYSTEMBiotex, Inc.·cleared 2007-08-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.