Device recall

Z-2602-2016: Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V)…

FDA device recall · Class II · Medtronic Neuromodulation

Key facts

Recall number (Z-number) Z-2602-2016
Recall event 74545
Product Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Product code MHY
Recalling firm Medtronic Neuromodulation
Recall class Class II
Status Terminated
Termination date Oct 3, 2016
PMA numbers P960009
FEI number 2182207

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)