Device recall

Z-1095-2022: Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135…

FDA device recall · Class I · Abbott Vascular

Key facts

Recall number (Z-number) Z-1095-2022
Recall event 90002
Product Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
Product code DQO
Recalling firm Abbott Vascular
Recall class Class I
Status Open, Classified
510(k) numbers K192019
FEI number 2024168

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 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)