Device recall

Z-0849-05: Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models…

FDA device recall · Class II · Edwards Lifesciences Llc

Key facts

Recall number (Z-number) Z-0849-05
Recall event 32030
Product Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D)
Product code MAF
Recalling firm Edwards Lifesciences Llc
Recall class Class II
Status Terminated
Termination date Oct 16, 2012
FEI number 2015691

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)