Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagul
Summary
The FDA issued a Class II for Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM T by Medtronic Navigation, Inc.. Reason: Due to a defect in the outer pouch sterile seal.
Details
Source
Device Recall
External ID
Z-0244-2023
Action Date
2022-11-23
Status
Ongoing
Category
device
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.
Lot/Code Info: Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, 0224824769
Quantity Affected: 95 units
Reason for Recall
Due to a defect in the outer pouch sterile seal
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-10-14
Company
Louisville, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 171 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic Navigation, Inc. has 23 FDA actions in our database, including 13 recalls and 10 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic Navigation, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic Navigation, Inc. have FDA actions?
Medtronic Navigation, Inc. has 23 FDA actions in our database, including 13 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0244-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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