Device recall

Z-0895-2022: Amplatzer Steerable Delivery Sheath

FDA device recall · Class II · Abbott

Key facts

Recall number (Z-number) Z-0895-2022
Recall event 89714
Product Amplatzer Steerable Delivery Sheath
Product code DQY
Recalling firm Abbott
Recall class Class II
Status Terminated
Termination date Aug 7, 2024
510(k) numbers K212026
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

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