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Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL w

Recalled January 8, 2025 · FDA recall Z-0773-2025 · Medtronic Neuromodulation

Hazard
Software issues were identified in application version 2.x. · FDA Class II
Units
566 systems
Sold at
Worldwide - US Nationwide distribution.

Description

Software issues were identified in application version 2.x.

Product
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
Manufacturer(s)
Medtronic Neuromodulation

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL w | RecallWatchUSA