The Recall Desk

Manufacturer

AESDEX

2 recalls in our database name AESDEX as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2018-07-25

Of the 2 recalls from AESDEX we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-2434-2018·2018-07-25

    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
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2433-2018·2018-07-25

    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
    Medical Device
    Distribution
    0 states