Recall Z-1672-2016 ยท GEX Powered Laser Surgical Instrument
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 th
| Date | May 16, 2016 (initiated May 9, 2016) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053087 | VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM Biotex, Inc., Mar 1, 2006 |