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U.S. Department of Health and Human Services

Class 2 Device Recall VNUS Medical UCLIP Removal Tool, UREM1860

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 Class 2 Device Recall VNUS Medical UCLIP Removal Tool, UREM1860see related information
Date Initiated by FirmFebruary 25, 2008
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on November 10, 2008
Recall NumberZ-1609-2008
Recall Event ID 47538
510(K)NumberK031623 
Product Classification A removal tool for an implantable clip (the U-Clip) - Product Code FZP
ProductVNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices.
Code Information Lot 0610315
FEI Number 3003368396
Recalling Firm/
Manufacturer		 Medtronic Cardiac Surgery Technologies
7601 Northland Dr N
Minneapolis MN 55428-1088
For Additional Information ContactMs. Preeti Jain
763-514-4000
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionA 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 in Commerce80
DistributionAZ, GA, PA, MI, KY, FL, OH, TX, NY, VA, CA, MO IL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FZP
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