Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase¿ Cooled Laser Applicator System 10mm Tip; c. Part Number 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: a. Part Number 9735559, UDI (00643169611986, 00643169933361), Lot Codes (0212782059, 0212894256, 0213251294, 0213331774, 0213383266, 0212783784, 0212926008, 0213259125, 0213335148, 0213383267, 0212823883, 0212956163, 0213299882, 0213375479, 0213387215, 0212823919, 0212978141, 0213299885, 0213378982, 0213537710, 0212854585, 0212996201, 0213327285, 0213383244, 0213966003, 0212882619, 0213519510); b. Part Number 9735560, UDI (00643169611993, 00643169933385), Lot Codes (0212086315, 0213158249, 0213299883, 0213427083, 0213728326, 0212698642, 0213158631, 0213304570, 0213455321, 0213735817, 0212715926, 0213158719, 0213304571, 0213458938, 0213737565, 0212745633, 0213165510, 0213304573, 0213507022, 0213760863, 0212753561, 0213165511, 0213308717, 0213507023, 0213760864, 0212756095, 0213205023, 0213309087, 0213512428, 0213760866, 0212760821, 0213205024, 0213334598, 0213512430, 0213769912, 0212827856, 0213208868, 0213368255, 0213513054, 0213917334, 0212838837, 0213212692, 0213368499, 0213513055, 0213922188, 0212843810, 0213223891, 0213368573, 0213513056, 0213924407, 0212846727, 0213223892, 0213373657, 0213540031, 0213924418, 0212856596, 0213242839, 0213374559, 0213576515, 0213928892, 0212873863, 0213245723, 0213375535, 0213576516, 0213945813, 0212873873, 0213258625, 0213375537, 0213576517, 0213945814, 0212879480, 0213259039, 0213375538, 0213594271, 0213966370, 0212913269, 0213259673, 0213375991, 0213594272, 0213972422, 0212922387, 0213259674, 0213376135, 0213594273, 0213973527, 0212935278, 0213267742, 0213376136, 0213596471, 0214032331, 0213000097, 0213289058, 0213376138, 0213699385, 0214043408, 0213001255, 0213289059, 0213376139, 0213699386, 0214045295, 0213009483, 0213292765, 0213376655, 0213699390, 0214049428, 0213041517, 0213292893, 0213376656, 0213710007, 0214062101, 0213044327, 0213296890, 0213376780, 0213710711, 0214066559, 0213056030, 0213296891, 0213377536, 0213710712, 0214068011, 0213107317, 0213298978, 0213378061, 0213720928, 0214068013, 0213116115, 0213299342, 0213387201, 0213720929, 0214068921, 0213134866, 0213299525, 0213388160, 0213728324, 0214068922, 0213136534, 0213518754, 0213138278); c. Part Number 9735561, UDI (00643169612006, 00763000015695, 00643169933378), Lot Codes (0212701679, 0212912501, 0212991152, 0213647807, 0213669275, 0212707035, 0212935757, 0213555835, 0213662428, 0213669402, 0212745660, 0212939348, 0213555836, 0213663333, 0213669408, 0212796559, 0212963182, 0213645747, 0213663500, 0213670155, 0212846726, 0212965542, 0213645760, 0213667299, 0213670722, 0212901580, 0212904407)
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Navigation, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Visualase Cooled Laser Applicator System (VCLAS) labeled as: a. Part Number 9735559, Visualase¿ Cooled Laser Applicator System 3mm Tip; b. Part Number 9735560 Visualase¿ Cooled Laser Applicator System 10mm Tip; c. Part Number 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.
Product Codes/Lot Numbers:
a. Part Number 9735559, UDI (00643169611986, 00643169933361), Lot Codes (0212782059, 0212894256, 0213251294, 0213331774, 0213383266, 0212783784, 0212926008, 0213259125, 0213335148, 0213383267, 0212823883, 0212956163, 0213299882, 0213375479, 0213387215, 0212823919, 0212978141, 0213299885, 0213378982, 0213537710, 0212854585, 0212996201, 0213327285, 0213383244, 0213966003, 0212882619, 0213519510); b. Part Number 9735560, UDI (00643169611993, 00643169933385), Lot Codes (0212086315, 0213158249, 0213299883, 0213427083, 0213728326, 0212698642, 0213158631, 0213304570, 0213455321, 0213735817, 0212715926, 0213158719, 0213304571, 0213458938, 0213737565, 0212745633, 0213165510, 0213304573, 0213507022, 0213760863, 0212753561, 0213165511, 0213308717, 0213507023, 0213760864, 0212756095, 0213205023, 0213309087, 0213512428, 0213760866, 0212760821, 0213205024, 0213334598, 0213512430, 0213769912, 0212827856, 0213208868, 0213368255, 0213513054, 0213917334, 0212838837, 0213212692, 0213368499, 0213513055, 0213922188, 0212843810, 0213223891, 0213368573, 0213513056, 0213924407, 0212846727, 0213223892, 0213373657, 0213540031, 0213924418, 0212856596, 0213242839, 0213374559, 0213576515, 0213928892, 0212873863, 0213245723, 0213375535, 0213576516, 0213945813, 0212873873, 0213258625, 0213375537, 0213576517, 0213945814, 0212879480, 0213259039, 0213375538, 0213594271, 0213966370, 0212913269, 0213259673, 0213375991, 0213594272, 0213972422, 0212922387, 0213259674, 0213376135, 0213594273, 0213973527, 0212935278, 0213267742, 0213376136, 0213596471, 0214032331, 0213000097, 0213289058, 0213376138, 0213699385, 0214043408, 0213001255, 0213289059, 0213376139, 0213699386, 0214045295, 0213009483, 0213292765, 0213376655, 0213699390, 0214049428, 0213041517, 0213292893, 0213376656, 0213710007, 0214062101, 0213044327, 0213296890, 0213376780, 0213710711, 0214066559, 0213056030, 0213296891, 0213377536, 0213710712, 0214068011, 0213107317, 0213298978, 0213378061, 0213720928, 0214068013, 0213116115, 0213299342, 0213387201, 0213720929, 0214068921, 0213134866, 0213299525, 0213388160, 0213728324, 0214068922, 0213136534, 0213518754, 0213138278); c. Part Number 9735561, UDI (00643169612006, 00763000015695, 00643169933378), Lot Codes (0212701679, 0212912501, 0212991152, 0213647807, 0213669275, 0212707035, 0212935757, 0213555835, 0213662428, 0213669402, 0212745660, 0212939348, 0213555836, 0213663333, 0213669408, 0212796559, 0212963182, 0213645747, 0213663500, 0213670155, 0212846726, 0212965542, 0213645760, 0213667299, 0213670722, 0212901580, 0212904407)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2501-2018
Related Recalls
Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.