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
Reported: January 8, 2025 Initiated: November 21, 2024 #Z-0772-2025
Product Description
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
Reason for Recall
Software issues were identified in application version 2.x.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 59 systems
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product 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. Recalled by Medtronic Neuromodulation. Units affected: 59 systems.
Why was this product recalled? ▼
Software issues were identified in application version 2.x.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 8, 2025. Severity: Moderate. Recall number: Z-0772-2025.
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