FDA Device recall Z-0137-2025
SynchroMed II Infusion Pump
- FDA Device
- Class II
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of SynchroMed II Infusion Pump by Medtronic Neuromodulation, citing potential for error and inability to interrogate pump due to data corruption in the pump memory.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0137-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-11 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
SynchroMed II Infusion Pump. Product Number: 8637-20
Reason
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Identifiers
| code_info | GTIN Number: 00643169630505. Serial Number: NGP004814H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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All Medtronic Neuromodulation recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0137-2025%22
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