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.
Enforcement
- Recall Number
- Z-2501-2018
- Event ID
- 80481
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Navigation, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 25, 2018
- Initiation Date
- March 23, 2018
- Classification Date
- July 19, 2018
- Termination Date
- July 31, 2023
- Address
- 826 Coal Creek Cir, Louisville, CO, 80027-9710, United States
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.
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.
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)
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI. International distribution to Israel.
1,283 devices total