Device recall

Z-0486-2025: Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z

FDA device recall · Class II · Maquet Cardiovascular, LLC

Key facts

Recall number (Z-number) Z-0486-2025
Recall event 95614
Product Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Product code MWS
Recalling firm Maquet Cardiovascular, LLC
Recall class Class II
Status Open, Classified
FEI number 2242352

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)