Z-0968-2007

Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool...

Name: Z-0968-2007 Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool...
Creator: Medtronic Cardiac Surgery Technologies
Published: 2007-02-08
License: https://open.fda.gov/license/

Medtronic Cardiac Surgery Technologies / initiated 2007-02-08 / Terminated

FDA source

Medtronic Cardiac Surgery Technologies began a recall of Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices on 2007-02-08. The reason FDA records is "Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0968-2007
Status: Terminated
Initiated: 2007-02-08
Posted: 2007-06-27
Terminated: 2008-02-24
Recalling firm: Medtronic Cardiac Surgery Technologies
Product: Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices.
Product code: FZP Clip, Implantable
Reason for recall: Six lots of U-Clip Removal Tools, catalog REM1860FW were incorrectly assembled. The nose cone attachment to the body of the removal tool does not contain sufficient adhesive which can cause the nose to separate from the body of the device.
FDA root cause: Other
Action: Customers to be notified via a letter on 2/8/07. The letter will explain the situation and requests that the impacted product be returned to Medtronic for disposal. The customer will be requested to complete a "Recall Certificate" acknowledging the receipt of this information.
Quantity in commerce: 187 (US 155, OUS 32)
Distribution: Nationwide and Canada.
Product codes and lots: lot numbers: 0610707, 0614409, 0614410, 0614411, 0614412, 0622204

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)