Visualase Cooled Laser Applicator System — Class II medical device recall Z-2501-2018
Terminated recall by Medtronic Navigation, Inc., reported 2018-07-25, distributed nationwide. Medtronic has become aware that certain lots of the VCLAS 3MM, 10MM, and 15MM laser diffusing fibers were not
| Recall number | Z-2501-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2018-03-23 |
| Classified | 2018-07-19 |
| Reported by FDA | 2018-07-25 |
| Terminated | 2023-07-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | IL |
| Quantity | 1,283 devices |
| UPC / GTIN / UDI-DI | 00643169611986, 00643169611993, 00643169612006, 00643169933361, 00643169933378, 00643169933385, 00763000015695 |
| Lot numbers | 0212698642, 0212707035, 0212715926, 0212745633, 0212745660, 0212753561, 0212756095, 0212760821, 0212783784, 0212796559, 0212823883, 0212823919, 0212827856, 0212838837, 0212843810, 0212846726, 0212846727, 0212854585, 0212856596, 0212873863, 0212873873, 0212879480, 0212882619, 0212894256, 0212901580, 0212912501, 0212913269, 0212922387, 0212926008, 0212935278, 0212935757, 0212939348, 0212956163, 0212963182, 0212965542, 0212978141, 0212991152, 0212996201, 0213000097, 0213001255 and 146 more |
| Model numbers | 9735559, 9735560, 9735561 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2501-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.