Device recall

Z-1700-2020: Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM…

FDA device recall · Class II · Abbott

Key facts

Recall number (Z-number) Z-1700-2020
Recall event 85275
Product Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
Product code NIK
Recalling firm Abbott
Recall class Class II
Status Terminated
Termination date Apr 18, 2024
PMA numbers P030035, P030035S177, P030054, P030054S373, P910023, P910023S422
FEI number 2017865

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)