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Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK w
Recalled January 8, 2025 · FDA recall Z-0771-2025 · Medtronic Neuromodulation
Hazard
Software issues were identified in application version 2.x. · FDA Class II
Units
319 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 CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →