Recall Z-0968-2007 ยท FZP Clip, Implantable
Medtronic Cardiac Surgery Technologies
Medtronic U-CLIP Anastomotic Device Removal Tool, model REM1860FW. The U-Clip Anastomotic Device Removal Tool is designed to remove U-Clip Anastomotic Devices.
| Date | Jun 27, 2007 (initiated Feb 8, 2007) |
| Status | Terminated |
| Reason | 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. |
| 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 | 187 (US 155, OUS 32) |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031623 | MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES Coalescent Surgical, Jul 3, 2003 |