FDA Device recall Z-0773-2025
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app…
- FDA Device
- Class II
- ongoing
- Published 2025-01-08
On 2025-01-08 the FDA classified a Class II recall of SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app… by Medtronic Neuromodulation, citing software issues were identified in application version 2.x.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0773-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-21 |
| Published | 2025-01-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
Reason
Software issues were identified in application version 2.x.
Identifiers
| code_info | GTIN: 00763000094027 00763000077730 00763000421007 00763000447090; Serial Numbers: NPL3000006 NPL3000007 NPL3000009 NPL…GTIN: 00763000094027 00763000077730 00763000421007 00763000447090; Serial Numbers: NPL3000006 NPL3000007 NPL3000009 NPL3000011 NPL3000016 NPL3000017 NPL3000023 NPL3000026 NPL3000029 NPL3000043 NPL3000046 NPL3000050 NPL3000055 NPL3000063 NPL3000068 NPL3000083 NPL3000090 NPL3000103 NPL3000105 NPL3000129 NPL3000185 NPL3000186 NPL3000187 NPL3000189 NPL3000191 NPL3000192 NPL3000197 NPL3000198 NPL3000203 NPL3000205 NPL3000206 NPL3000209 NPL3000210 NPL3000215 NPL3000216 NPL3000219 NPL3000222 NPL3000223 NPL3000229 NPL3000232 NPL3000237 NPL3000240 NPL3000242 NPL3000246 NPL3000248 NPL3000250 NPL3000252 NPL3000253 NPL3000255 NPL3000262 NPL3000264 NPL3002259 NPL3002261 NPL3002266 NPL3002273 NPL3002274 NPL3002275 NPL3002278 NPL3002283 NPL3002288 NPL3002296 NPL3002306 NPL3002655 NPL3002660 NPL3002661 NPL3002666 NPL3002667 NPL3002669 NPL3002670 NPL3002672 NPL3002679 NPL3002685 NPL3002686 NPL3002687 NPL3002693 NPL3002694 NPL3002699 NPL3002700 NPL3002702 NPL3002703 NPL3002704 NPL3002705 NPL3002706 NPL3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0773-2025%22
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