Recall Z-0774-2025— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2024-11-21. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Software issues were identified in application version 2.x..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-21
- Firm location
- Minneapolis, MN, United States
Product description
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
Reason for recall
Software issues were identified in application version 2.x.
Data sourced from openFDA. This site is unofficial and independent of the FDA.