Device recall

Z-1201-2021: Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions…

FDA device recall · Class I · Medtronic Vascular, Inc.

Key facts

Recall number (Z-number) Z-1201-2021
Recall event 87379
Product Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
Product code MIH
Recalling firm Medtronic Vascular, Inc.
Recall class Class I
Status Open, Classified
PMA numbers P100040, P100040S036
FEI number 3005364322

At a glance

  • None 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)