Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AesDex Recalled by AESDEX Due to Following pressurization of the devices, damage to the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact AESDEX directly.
Affected Products
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 interrupted stitch anastomosis. The system consists of one Anastomosis Device and one Retractor Mount.
Quantity: 587 units
Why Was This 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.
Where Was This Sold?
U.S. and international: Belgium, Germany, Italy and Netherlands. No gov accounts.
About AESDEX
AESDEX has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report