Visualase recallZ-0244-2023 · Medtronic Navigation, Inc. · initiated Oct 14, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Navigation, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to a defect in the outer pouch sterile seal
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-0244-2023
- Status
- Open, Classified
- Initiated by the company
- Oct 14, 2022
- Posted by the FDA
- Nov 17, 2022
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 95 units
- Product code
- ONO
- FDA submissions
- K181859, K211269, K053087
- 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.
Product description
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 (models, lots, serial numbers)
Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Visualase 9735560Medtronic Navigation, Inc. · Neurosurgical laser with MR thermography1 recall59 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K181859, K211269, K053087 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Visualase 9735542Medtronic Navigation, Inc. · Powered laser surgical instrument20 reports
- VISUALASE 9735542Medtronic Navigation, Inc. · Neurosurgical laser with MR thermography2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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