Device recall

Z-1555-2020: Imager II 5F Angiographic Catheters, 5 units per package.

FDA device recall · Class I · Boston Scientific Corporation

Key facts

Recall number (Z-number) Z-1555-2020
Recall event 84886
Product Imager II 5F Angiographic Catheters, 5 units per package.
Product code DQO
Recalling firm Boston Scientific Corporation
Recall class Class I
Status Open, Classified
510(k) numbers K121694
FEI number 3002095335

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)