Device recall

Z-1800-2024: Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP 9 Ga (11 Fr)…

FDA device recall · Class II · Medtronic Perfusion Systems

Key facts

Recall number (Z-number) Z-1800-2024
Recall event 94274
Product Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard", Model Number 11014L
Product code DWF
Recalling firm Medtronic Perfusion Systems
Recall class Class II
Status Open, Classified
510(k) numbers K182586
FEI number 1000116158

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 Products in the same recall event
  • 100–999 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

Browse all FDA device recalls (products)