Reported Jul 25, 2018 · Terminated
Visualase Cooled Laser Applicator System (VCLAS) labeled as
Medtronic Navigation, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Navigation, Inc. · 826 Coal Creek Cir · Louisville, CO · 80027-9710
Is this the product you have?
Visualase Cooled Laser Applicator System (VCLAS) labeled as
3 of 3 products
| Model / number | Product as published |
|---|---|
9735559 | Visualase¿ Cooled Laser Applicator System 3mm Tip |
9735560 | Visualase¿ Cooled Laser Applicator System 10mm Tip |
9735561 | Visualase¿ Cooled Laser Applicator System 15mm Tip Product Usage: The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800 nm - 1060 nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images to determine relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time. |
- Lot codes and dates
202 of 202 codes
a. Part Number 9735559UDI (0064316961198600643169933361)Lot Codes (021278205902128942560213251294021333177402133832660212783784021292600802132591250213335148021338326702128238830212956163021329988202133754790213387215021282391902129781410213299885021337898202135377100212854585021299620102133272850213383244021396600302128826190213519510)b. Part Number 9735560UDI (0064316961199300643169933385)Lot Codes (021208631502131582490213299883021342708302137283260212698642021315863102133045700213455321021373581702127159260213158719021330457102134589380213737565021274563302131655100213304573021350702202137608630212753561021316551102133087170213507023021376086402127560950213205023
- Amount recalled
- 1,283 devices total
Where it was sold
Why it was recalled
Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not tested at intended laser power levels, due to an issue related to calibration of the test equipment, which can lead to the potential for low laser energy output from fiber or fiber burnout at lower wattage.
This product could cause temporary or reversible health problems — stop using it.
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