Z-1609-2008

VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices

Name: Z-1609-2008 VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices
Creator: Medtronic Cardiac Surgery Technologies
Published: 2008-02-25
License: https://open.fda.gov/license/

Medtronic Cardiac Surgery Technologies / initiated 2008-02-25 / Terminated / root cause: manufacturing process

FDA source

Medtronic Cardiac Surgery Technologies began a recall of VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices on 2008-02-25. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1609-2008
Status: Terminated
Initiated: 2008-02-25
Posted: 2008-09-16
Terminated: 2008-11-10
Recalling firm: Medtronic Cardiac Surgery Technologies
Product: VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices.
Product code: FZP Clip, Implantable
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 80
Distribution: AZ, GA, PA, MI, KY, FL, OH, TX, NY, VA, CA, MO IL.
Product codes and lots: Lot 0610315

Product code FZP

K031623Class IIModification to Coalescent Surgical U-Clip and AccessoriesCoalescent Surgical / cleared 2003-07-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)