Device recall

Z-0508-2020: Synchromed II programmable pump, Model numbers 8637-20 and 8637-40

FDA device recall · Class I · Medtronic Neuromodulation

Key facts

Recall number (Z-number) Z-0508-2020
Recall event 84037
Product Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Product code LKK
Recalling firm Medtronic Neuromodulation
Recall class Class I
Status Terminated
Termination date Sep 15, 2023
PMA numbers P860004
FEI number 2182207

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)