Class 2 Device Recall Visualase Cooled Laser Applicator System (VCLAS)

• Date Initiated by Firm: October 14, 2022
• Date Posted: November 17, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0244-2023
• Recall Event ID: 91041
• 510(K)Number: K211269 K181859 K053087
• Product Classification: Neurosurgical laser with MR thermography - Product Code ONO
• Product: Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE; FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.
• Code Information: Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769
• Recalling Firm/ Manufacturer: Medtronic Navigation, Inc.; 826 Coal Creek Cir; Louisville CO 80027-9710
• For Additional Information Contact: Naomi Rodiles; 612-427-5521
• Manufacturer Reason for Recall: Due to a defect in the outer pouch sterile seal
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 10/03/2022, the firm verbally notified affected customers and on 10/14/2022 sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter to customer informing them that Medtronic identified a breach to the sterile barrier of the outer pouch of specific lots of VCLAS 9735560 .4MM Core Fiber 10MM Tip products. Customer are instructed to: immediately identify and segregate affected products within your inventory. Medtronic will contact you to facilitate product replacement when unaffected product is available. Medtronic has determined that the inner pouches maintain sterility, accordingly, you may use segregated products ensuring the following sterile technique workflow is followed: 1. Open the affected outer pouch outside of the sterile field and remove the smaller internal pouches. 2. Per the Instruction for Use: Prior to use, examine the product packaging (in this instance the inner pouch) for damage, deterioration, and expired shelf life. If found, do not use the product. 3. Open the internal pouches using sterile technique and carefully transfer the sterile contents into the sterile field. For questions, contact Medtronic Technical Service at 1-888-826-5603 or email at rs.navtechsupport@medtronic.com
• Quantity in Commerce: 95 units
• Distribution: U.S. Nationwide distribution including in the states AZ, CA, CO, DC, FL, IL, KY, MA, MD, ME, MI, MN, MO, NH, NJ, NY, OH, PA, RI, TX, VA, WA, and WV.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = ONO and Original Applicant = BIOTEX, INC.; 510(K)s with Product Code = ONO and Original Applicant = Medtronic Navigation Inc.; 510(K)s with Product Code = ONO and Original Applicant = Medtronic Navigation, Inc.