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.
Recall
- Recall Number
- Z-2501-2018
- Event Number
- 80481
- Firm
- Medtronic Navigation, Inc.
- FEI Number
- 1000517638
- Product Code
- GEX
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- March 23, 2018
- Terminated
- July 31, 2023
- Address
- 826 Coal Creek Cir, Louisville, CO, 80027-9710
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.
Customers were notified on about 03/23/2018 via URGENT: MEDICAL DEVICE RECALL letter. Instructions included to examine inventory for affected devices, contact Medtronic Technical Services at 1-888-826-5603 to arrange for the return of affected devices, and complete and return the Consignee Response Form. The recall was later expanded and customers were notified on about 05/16/2018 URGENT: MEDICAL DEVICE RECALL letter. Instructions did not change from the initial letter, but informed customers that the recall had been expanded to include two (2) additional lots.
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