Device recall

Z-0753-2025: The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650…

FDA device recall · Class II · Abbott Medical

Key facts

Recall number (Z-number) Z-0753-2025
Recall event 95813
Product The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.
Product code PNJ
Recalling firm Abbott Medical
Recall class Class II
Status Open, Classified
PMA numbers P150035, P150035S013
FEI number 2017865

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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)