Recall Z-2167-2013 ยท GCJ Laparoscope, General & Plastic Surgery
Xlumena, Inc.
Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation balloon that creates and dilates a tract across tissue planes. The NAVIX Access Device is indicated for use as an accessory to c
| Date | Sep 9, 2013 (initiated Apr 17, 2013) |
| Status | Terminated |
| Reason | A complaint investigation has found that product fractures can occur at the distal end of the catheter under load. |
| Root cause | Process design |
| Action | Xlumena sent an Urgent Medical Device Recall letter dated April 17, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and segregate the affected product. Customers with questions were instructed to contact dhasker@xlumena.com. For question regarding this recall call 650-961-9901. |
| Quantity | 148 units |
| Distribution | Worldwide Distribution - USA including AZ, CA, FL, GA, IN, NY,SC, WA, PA, IL, CO, and internationally to Netherlands, Germany, Spain, Denmark, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093279 | NAVIX ACCESS DEVICE Xlumena, Apr 7, 2010 |