Device recall

Z-1076-2022: Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number…

FDA device recall · Class I · Atrium Medical Corporation

Key facts

Recall number (Z-number) Z-1076-2022
Recall event 89852
Product Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360 85361 85364 85365 85388…
Product code JCT
Recalling firm Atrium Medical Corporation
Recall class Class I
Status Open, Classified
FEI number 3011175548

At a glance

  • None 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

Browse all FDA device recalls (products)