Recall Z-1609-2008 ยท FZP Clip, Implantable
Medtronic Cardiac Surgery Technologies
VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices.
| Date | Sep 16, 2008 (initiated Feb 25, 2008) |
| Status | Terminated |
| Reason | Medtronic has identified one lot #0610315 of U-Clip Removal Tools, Catalog UREM1860FW, that was incorrectly assembled. The nose cone attachment, on the body of the removal tool, may not contain sufficient adhesive, which can allow the nose cone to separate from the body of the device. |
| Root cause | Process control |
| Action | A Medtronic "Urgent Medical Device Field Notification" letter was sent to one distributor and a separate consignee Medtronic letter "Urgent Medical Device Field Notification" was sent to end users on February 25, 2008. The letters explained the situation and requested that the impacted product be returned to Medtronic for disposal. The end user will be requested to complete a Recall certificate acknowledging the receipt of the information. If you have questions, contact your VNUS Sales Representative or Lauralie Millikan at 763-391-9124. |
| Quantity | 80 |
| Distribution | AZ, GA, PA, MI, KY, FL, OH, TX, NY, VA, CA, MO IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031623 | MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES Coalescent Surgical, Jul 3, 2003 |