Device recall

Z-0604-05: Medtronic InSync II Marquis, model 7289 Dual Chamber Implantable Cardioverter…

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

Key facts

Recall number (Z-number) Z-0604-05
Recall event 31142
Product Medtronic InSync II Marquis, model 7289 Dual Chamber Implantable Cardioverter Defibrillator (ICD) with Cardiac Resynchronization Therapy devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected…
Product code NIK
Recalling firm Medtronic Inc. Cardiac Rhythm Managment
Recall class Class II
Status Terminated
Termination date Dec 28, 2006
PMA numbers P010031, P010031S005
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)