Device recall

Z-0230-2023: Superion Indirect Decompression System (IDS) Model Numbers and Size: 101-9808…

FDA device recall · Class II · Boston Scientific Neuromodulation Corporation

Key facts

Recall number (Z-number) Z-0230-2023
Recall event 90915
Product Superion Indirect Decompression System (IDS) Model Numbers and Size: 101-9808 - 8mm 01-9812 - 12mm 101-9814 - 14mm
Product code NQO
Recalling firm Boston Scientific Neuromodulation Corporation
Recall class Class II
Status Open, Classified
PMA numbers P140004
FEI number 3006630150

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)