Recall Z-2434-2018 ยท FZP Clip, Implantable
AESDEX
AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel and conduit. The stainless steel clips create a complete end-to-side anastomosis that is functionally equivalent to a hand-sutured interrupted stitch anastomosis.
| 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 | 400 umits |
| Distribution | U.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts. |
| FDA record | Open on fda.gov |