Medtronic Visualase Cooled Laser Applicator Sterile Seal Defect Recall
Medtronic is recalling 95 units of Visualase Cooled Laser Applicator System devices due to a defect in the outer pouch sterile seal. Affected devices were distributed nationwide to healthcare facilities.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device recall involves a sterile seal defect that poses a risk of contamination in a surgical instrument. No illnesses or injuries have been reported, but the defect qualifies as a risk-of-harm condition in an invasive surgical device.
Plain-English summary
Medtronic Navigation, Inc. is recalling 95 units of the Visualase Cooled Laser Applicator System (VCLAS), model 9735560 with 0.4mm core fiber and 10mm tip. The recall is due to a defect in the outer pouch sterile seal.
The affected devices were distributed nationwide throughout the United States, including Arizona, California, Colorado, Washington DC, Florida, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and West Virginia. The affected lot numbers are 0224382403, 0224779378, 0224824522, 0224824523, 0224824525, 0224824767, 0224824768, and 0224824769.
The Visualase Cooled Laser Applicator System is used by physicians to necrotize or coagulate soft tissue during minimally invasive surgical procedures. A defect in the sterile seal of the outer pouch could compromise the sterility of the device, potentially allowing contamination.
Healthcare facilities that have received these affected devices should identify and quarantine units with the listed lot numbers and contact Medtronic for instructions on return or replacement. Do not use affected devices until further guidance is received from the manufacturer.
The recalled product
- 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.
- Manufacturer
- Medtronic Navigation, Inc.
- Hazard
- sterile-seal-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Product Number/CFN: 9735560 UDI-DI Code: 00763000416430 Lot Numbers: 0224382403
- 0224779378
- 0224824522
- 0224824523
- 0224824525
- 0224824767
- 0224824768
- 0224824769
Distribution
Distributed nationwide across the United States.
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