Visualase Cooled Laser Applicator System (VCLAS). The VCLAS system consists of the Visualase Laser Diffusing Fiber (LDF)
FDA device recall Z-1672-2016 · posted 2016-05-16 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
- Action taken
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- GEX
- Quantity affected
- 120
- Distribution
- Distributed within the US, Netherlands, Canada and Australia and to govt/VA/military consignees.
- Date initiated
- 2016-05-09
- Date posted
- 2016-05-16
- Date terminated
- 2016-12-19
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISUALASE COOLED LASER APPLICATOR SYSTEM, LASER DIFFUSING FIBER, COOLING CATHETER SYSTEM (K053087) | Biotex, Inc. | 2006-03-01 |