VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices.
This recall has been terminated (originally issued September 16, 2008).
- Recall Initiated
- February 25, 2008
- Posted
- September 16, 2008
- Terminated
- November 10, 2008
- Recall Number
- Z-1609-2008
- Quantity
- 80
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
AZ, GA, PA, MI, KY, FL, OH, TX, NY, VA, CA, MO IL.
Lot / Code Info
Lot 0610315
Root Cause
Process control
Action Taken
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.