FDA Medical Device Recalls (openFDA)
Medtronic Navigation, Inc.: Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.
- Recall number
- Z-1672-2016
- Recalling firm
- Medtronic Navigation, Inc.
- Product
- Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF) and the Visualase Cooled Catheter System (CCS). The LDF and disposables (including the CCS) is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels of the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, pulmonology, radiology and urology.
- Status
- Terminated
- Initiated
- 2016-05-09
- Posted
- 2016-05-16
- Terminated
- 2016-12-19
- Reason
- Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
- Root cause
- Labeling design
- Action
- Medtronic will be sending a Medical Device Safety Notification letter FedEx on May 18, 2016. Each customer will be asked to complete and return a response form to Medtronic. This is a safety alert notification and does not require return of devices. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this action, please contact Medtronic Technical Services at 1-800-595-9709.
- Quantity
- 120
- Distribution
- Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.
- Lot, serial or model codes
- All lot numbers manufactured by BioTex are affected for Model Numbers: T03: 001-4003 - VCLAS 001-4003 .4mm CORE FIBER 3mm TIP T10: 001-4000 - VCLAS 001-4000 .4mm CORE FIBER 10mm TIP T15: 001-6000 - VCLAS 001-6000 .6mm CORE FIBER 15mm TIP
- 510(k) numbers
- ["K053087"]
- PMA numbers
- not on file
- Product code
- GEX
- Firm FEI
- 1000517638
- Firm city
- Louisville
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28