VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices.
FDA Recall Z-1609-2008 · Posted 2008-09-16
Recalling FirmMedtronic Cardiac Surgery Technologies
Recall StatusTerminated
Product CodeFZP
Date Initiated2008-02-25
Date Terminated2008-11-10
Product Quantity80
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
AZ, GA, PA, MI, KY, FL, OH, TX, NY, VA, CA, MO IL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.