Device recall

Z-1976-2021: Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For…

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

Key facts

Recall number (Z-number) Z-1976-2021
Recall event 88028
Product Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
Product code MIH
Recalling firm Medtronic Vascular, Inc.
Recall class Class II
Status Terminated
Termination date Apr 5, 2024
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)