Z-0244-2023Class II

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

Name: Z-0244-2023 Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize...
Creator: Medtronic Navigation, Inc.
Published: 2022-10-14
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2022-10-14 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc. began a recall of Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in... on 2022-10-14. FDA classified it as Class II and gives the reason as "Due to a defect in the outer pouch sterile seal". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0244-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-14
Posted: 2022-11-17
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.
Product code: ONO Neurosurgical Laser With Mr Thermography
Reason for recall: Due to a defect in the outer pouch sterile seal
Root cause tag: manufacturing process
FDA 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 [email protected]
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.
Product codes and lots: Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0244-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0244-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-23	2022-11-17

Product code ONO

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)