FDA-Device2025-01-08Class II
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
Medtronic Neuromodulation
Hazard
Software issues were identified in application version 2.x.
Sold states
Worldwide - US Nationwide distribution.
Affected count
566 systems
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0773-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief