Device recall

Z-0024-2025: iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616

FDA device recall · Class II · Atrium Medical Corporation

Key facts

Recall number (Z-number) Z-0024-2025
Recall event 95329
Product iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Product code PRL
Recalling firm Atrium Medical Corporation
Recall class Class II
Status Open, Classified
FEI number 3011175548

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)