AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis… recallZ-2434-2018 · Aesdex · initiated Apr 2, 2018
Class II Terminated All recalls posted in July 2018
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aesdex or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2434-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 2, 2018
- Posted by the FDA
- Jul 13, 2018
- Recalling firm
- Aesdex
- Quantity
- 400 umits
- Product code
- FZP
- FDA submissions
- K070548, K073123
- Distribution
- U.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts.
Product description
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. The system consists of one Anastomosis Device and one Retractor Mount. The system is designed with a flexible shaft to facilitate access to difficult to reach coronary targets.
Code information (models, lots, serial numbers)
UDI: (01) 1 18 14900 00150 2 Lot numbers: 141118H, 151026C, 151118B, 160205A, 160805A, 160805B, 161128C, 161111D, 170222L, 170322J, 170712A, 170907D, 171201C, 171207C, 180103B.
Other devices under the same FDA submission
1 device cleared under K070548, K073123 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Cardica C-Port Flex-A Plus Distal Anastomosis System FG-000150Aesdex, LLC · Clip, Implantable3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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