FDA Medical devices recall ·
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps… recall
- Recall number
- Z-0774-2025
- Date
- (initiated November 21, 2024)
- Company / brand
- Medtronic Neuromodulation
7000 Central Ave Ne, Minneapolis, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 3981 systems
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Software issues were identified in application version 2.x.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN: 00763000447090 00763000729141 00763000737290 00763000447090; Serial Numbers: NPL3020725 NPL3021958 NPL3021963 NPL3021966 NPL3021969 NPL3021970 NPL3021971 NPL3021974 NPL3021983 NPL3021984 NPL3021990 NPL3021997 NPL3022002 NPL3022005 NPL3022014 NPL3022022 NPL3022031 NPL3022032 NPL3022038 NPL3022044 NPL3022052 NPL3022062 NPL3022069 NPL3022070 NPL3022071 NPL3022072 NPL3022073 NPL3022074 NPL3022109 NPL3022114 NPL3022118 NPL3022124 NPL3022125 NPL3022131 NPL3022139 NPL3022187 NPL3022190 NPL3022193 NPL3022194 NPL3022195 NPL3022212 NPL3022213 NPL3022216 NPL3022218 NPL3022245 NPL3022257 NPL3022278 NPL3022280 NPL3022289 NPL3022291 NPL3022304 NPL3022311 NPL3022313 NPL3022314 NPL3022328 NPL3022352 NPL3022357 NPL3022364 NPL3022365 NPL3022711 NPL3022713 NPL3022714 NPL3022715 NPL3022717 NPL3022735 NPL3022761 NPL3022762 NPL3022765 NPL3022767 NPL3022768 NPL3022769 NPL3022776 NPL3022791 NPL3022793 NPL3022795 NPL3022810 NPL3022811 NPL3022815 NPL3022817 NPL3022818 NPL3022831 NPL3022836 NPL3022838 NPL3022841 NPL3022844 NPL3022856 NPL3022858 NPL3022869 NPL3022870 NPL3022873 NPL3022874 NPL3022876 NPL3022877 NPL3022879 NPL3022893 NPL3022899 NPL3022900 NPL3022912 NPL3022918 NPL3022922 NPL3022926 NPL3022939 NPL3022940 NPL3022942 NPL3022954 NPL3022957 NPL3022958 NPL3022959 NPL3022968 NPL3022969 NPL3022973 NPL3022974 NPL3022981 NPL3022999 NPL3023030 NPL3023032 NPL3023035 NPL3023038 NPL3023042 NPL3023043 NPL3023048 NPL3023050 NPL3023054 NPL3023059 NPL3023061 NPL3023065 NPL3023067 NPL3023076 NPL302307
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0774-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.