Medtronic Neuromodulation recalls SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with…
- Recall date
- November 21, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0772-2025
- FDA classification
- Class II
- Brand / firm
- Medtronic Neuromodulation
- Sold / distributed
- Worldwide - US Nationwide distribution.
Why it was recalled
Software issues were identified in application version 2.x.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
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