Device recall

Z-2434-2018: AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog…

FDA device recall · Class II · AESDEX

Key facts

Recall number (Z-number) Z-2434-2018
Recall event 80319
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 create a complete…
Product code FZP
Recalling firm AESDEX
Recall class Class II
Status Terminated
Termination date Apr 27, 2021
510(k) numbers K070548, K073123
FEI number 3004114958

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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