Device recall

Z-0987-2025: Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model…

FDA device recall · Class II · St. Jude Medical

Key facts

Recall number (Z-number) Z-0987-2025
Recall event 95706
Product Merlin.net Patient Care Network (PCN) Heart Failure Web Application (Model MN6000) (Which interfaces with CardioMEMS" Hospital System model CM3100) The CardioMEMS" HF System provides pulmonary artery (PA) hemodynamic data used for monitoring and management of heart failure (HF) patients. The system…
Product code MOM
Recalling firm St. Jude Medical
Recall class Class II
Status Open, Classified
PMA numbers P100045
FEI number 3004936110

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)