Recall Z-2433-2018 ยท FZP Clip, Implantable
AESDEX
AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Number FG-000100. The Cardica C-Port xA PLUS Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel (e.g. coronary artery) and conduit (e.g. saphenous vein graft). The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured int
| Date | Jul 13, 2018 (initiated Apr 2, 2018) |
| Status | Terminated |
| Reason | Following pressurization of the devices, damage to the device handle mechanism may occur, accompanied by a loud noise and potential dispersion of plastic fragments and components. |
| Root cause | Under Investigation by firm |
| Action | AesDex, LLC initiated a voluntary removal via Advisory Notice that was sent to all consignees in the United States on April 2 and 3, 2018. The Advisory Notice describes the issue, and instructs the consignees to stop any use of any product they may have in their inventory and return any unused product. The notice was sent via FedEx and a response form has been included with the notice in which the consignee is requested to fill-out the response form and return the response form to AesDex via Fax or email. |
| Quantity | 587 units |
| Distribution | U.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053524 | C-PORT DISTAL ANASTOMOSIS SYSTEM Cardica, Inc., Nov 16, 2006 |
| K063644 | CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM Cardica, Inc., Jan 11, 2007 |
| K090872 | MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM Cardica, Inc., Apr 21, 2009 |
| K101018 | CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100 Cardica, Inc., Jun 25, 2010 |