Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices.
FDA Recall Z-0968-2007 · Posted 2007-06-27
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Recalling FirmMedtronic Cardiac Surgery Technologies
Recall StatusTerminated
Product CodeFZP
Date Initiated2007-02-08
Date Terminated2008-02-24
Product Quantity187 (US 155, OUS 32)
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide and Canada.
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.
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