Device recall

Z-0130-2010: This device is not approved in the United States. Medtronic Virtuoso DR…

FDA device recall · Class II · Medtronic Inc. Cardiac Rhythm Disease Managment

Key facts

Recall number (Z-number) Z-0130-2010
Recall event 53294
Product This device is not approved in the United States. Medtronic Virtuoso DR, D164AWG. Medtronic, Inc., Minneapolis, MN 55432 USA.
Product code LWS
Recalling firm Medtronic Inc. Cardiac Rhythm Disease Managment
Recall class Class II
Status Terminated
Termination date May 29, 2012
FEI number 2182208

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)