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Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMS
Recalled January 8, 2025 · FDA recall Z-0774-2025 · Medtronic Neuromodulation
Hazard
Software issues were identified in application version 2.x. · FDA Class II
Units
3981 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 CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →