FDA Medical Device Recalls (openFDA)
Medtronic Cardiac Surgery Technologies: VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices.
- Recall number
- Z-1609-2008
- Recalling firm
- Medtronic Cardiac Surgery Technologies
- Product
- VNUS Medical U-CLIP Removal Tool, UREM1860, is intended for the removal of U-Clip anastomotic devices.
- Status
- Terminated
- Initiated
- 2008-02-25
- Posted
- 2008-09-16
- Terminated
- 2008-11-10
- 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.
- Lot, serial or model codes
- Lot 0610315
- 510(k) numbers
- ["K031623"]
- PMA numbers
- not on file
- Product code
- FZP
- Firm FEI
- 3003368396
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28