Device recall

Z-2168-2025: Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the…

FDA device recall · Class II · Medtronic, Inc.

Key facts

Recall number (Z-number) Z-2168-2025
Recall event 97130
Product Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Model Number D00U009; 3. Evera MRI application, Software Model Number D00U010; 3. Visia…
Product code NVZ
Recalling firm Medtronic, Inc.
Recall class Class II
Status Open, Classified
PMA numbers P890003
FEI number 2182208

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)