Company: Medtronic Neuromodulation
Date of Enforcement Report: 12/27/2024
Class II
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
Recall Number:
Z-0771-2025
REASON:
Software issues were identified in application version 2.x.
RECALLING FIRM/MANUFACTURER:
Medtronic Neuromodulation
VOLUME OF PRODUCT IN COMMERCE:
319 systems
DISTRIBUTION:
Worldwide – US Nationwide distribution.
