Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulat

FDA device recall Z-0244-2023 · posted 2022-11-17 · Open, Classified

Recall details

Recalling firm

Medtronic Navigation, Inc.

Reason for recall

Due to a defect in the outer pouch sterile seal

Action taken

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

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

ONO

Quantity affected

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.

Date initiated

2022-10-14

Date posted

2022-11-17

Location

Louisville, CO

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