Device recall

Z-2201-2026: Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software…

FDA device recall · Class II · Medtronic Neuromodulation

Key facts

Recall number (Z-number) Z-2201-2026
Recall event 98750
Product Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4…
Product code LKK
Recalling firm Medtronic Neuromodulation
Recall class Class II
Status Open, Classified
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)