FDA Device recall Z-0771-2025
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK 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 CT900B CLINICIAN TABLET EU -UK 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-0771-2025 |
| 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 CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
Reason
Software issues were identified in application version 2.x.
Identifiers
| code_info | GTIN: 00643169890947, 00763000447090; Serial Numbers: NPL1000037 NPL1000042 NPL1000045 NPL1000048 NPL1000051 NPL1000054…GTIN: 00643169890947, 00763000447090; Serial Numbers: NPL1000037 NPL1000042 NPL1000045 NPL1000048 NPL1000051 NPL1000054 NPL1000055 NPL1000056 NPL1000062 NPL1000069 NPL1000072 NPL1000073 NPL1000074 NPL1000075 NPL1000078 NPL1000083 NPL1000092 NPL1000093 NPL1000094 NPL1000096 NPL1000098 NPL1000132 NPL1000151 NPL1000159 NPL1000161 NPL1000165 NPL1000166 NPL1000173 NPL1000174 NPL1000179 NPL1000180 NPL1000185 NPL1000186 NPL1000189 NPL1000191 NPL1000195 NPL1000196 NPL1000230 NPL1000233 NPL1000238 NPL1000239 NPL1000249 NPL1000257 NPL1000281 NPL1000297 NPL1000301 NPL1000303 NPL1000321 NPL1000323 NPL1000325 NPL1000331 NPL1000334 NPL1000343 NPL1000344 NPL1000361 NPL1000363 NPL1000367 NPL1000370 NPL1000486 NPL1000501 NPL1000504 NPL1000505 NPL1000506 NPL1000507 NPL1000509 NPL1000510 NPL1000515 NPL1000516 NPL1000518 NPL1000519 NPL1000528 NPL1000555 NPL1000556 NPL1000558 NPL1000561 NPL1000562 NPL1000563 NPL1000571 NPL1000573 NPL1000574 NPL1000584 NPL1000585 NPL1000592 NPL1000603 NPL1000606 NPL1000612 |
|---|
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-0771-2025%22
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