The Recall Desk

FDA (Devices) recall action 80319

AESDEX recalled 2 products on 2018-07-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-07-25
Critical
0
Units
987

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • HighFDA (Devices)··2018-07-25

    AesDex Cardica C-Port Flex-A PLUS Distal Anastomosis System Recalled for Handle Damage

    AesDex is recalling the Cardica C-Port Flex-A PLUS Distal Anastomosis System because the handle mechanism may be damaged during use, potentially causing plastic fragments to disperse.

    Product
    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 cr
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2018-07-25

    AesDex Cardica C-Port xA PLUS Anastomosis System Recalled for Handle Damage

    AesDex is recalling 587 Cardica C-Port xA PLUS Anastomosis Systems because the handle mechanism may break during use, causing a loud noise and potential dispersion of plastic fragments.

    Product
    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)
    Category
    Distribution
    0 states