FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.: 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.
- Recall number
- Z-0244-2023
- Recalling firm
- Medtronic Navigation, Inc.
- 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.
- Status
- Open, Classified
- Initiated
- 2022-10-14
- Posted
- 2022-11-17
- Terminated
- not on file
- Reason
- Due to a defect in the outer pouch sterile seal
- Root 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
- 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.
- Lot, serial or model codes
- Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769
- 510(k) numbers
- ["K053087","K181859","K211269"]
- PMA numbers
- not on file
- Product code
- ONO
- Firm FEI
- 1000517638
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28