Device recall

Z-0594-2010: Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model…

FDA device recall · Class II · Endologix Inc

Key facts

Recall number (Z-number) Z-0594-2010
Recall event 53983
Product Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.
Product code OAD
Recalling firm Endologix Inc
Recall class Class II
Status Terminated
Termination date May 7, 2010
PMA numbers P040042
FEI number 1000125107

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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)