Device recall

Z-2110-2023: Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a…

FDA device recall · Class I · Abbott

Key facts

Recall number (Z-number) Z-2110-2023
Recall event 92502
Product Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Product code DQY
Recalling firm Abbott
Recall class Class I
Status Open, Classified
510(k) numbers K220340
FEI number 3005334138

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)