Recall Z-0025-2018— Medtronic Navigation, Inc.

Name: FDA recall Z-0025-2018
Creator: U.S. Food and Drug Administration
Published: 2017-07-27

Class II · Terminated

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2017-07-27, terminated 2019-08-05. It names one FDA 510(k) clearance: K053087. 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: The VCLAS 3mm, 10mm, and 15mm tip devices were not appropriately tested for saline leakage during the manufacturing process..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-07-27
Terminated: 2019-08-05
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K053087 — VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEMBiotex, Inc.·cleared 2006-03-01

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

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.

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