Device recall

Z-0730-2025: 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in…

FDA device recall · Class II · Abbott Vascular Inc

Key facts

Recall number (Z-number) Z-0730-2025
Recall event 95707
Product 20/30 INDEFLATOR, REF: 1000184, for use during cardiovascular procedures in conjunction with interventional devices such as balloon dilatation catheters to create and monitor pressure in the balloon.
Product code MAV
Recalling firm Abbott Vascular Inc
Recall class Class II
Status Open, Classified
510(k) numbers K961471
FEI number 2024168

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

Browse all FDA device recalls (products)