Device recall

Z-2359-2024: Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only

FDA device recall · Class II · Abbott Medical

Key facts

Recall number (Z-number) Z-2359-2024
Recall event 94798
Product Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
Product code LGW
Recalling firm Abbott Medical
Recall class Class II
Status Open, Classified
FEI number 1627487

At a glance

  • None Linked 510(k)s
  • 10–99 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)