FDA Device recall Z-1694-2017
SynchroMed II implantable drug infusion pump, Model 8637-40
- FDA Device
- Class II
- terminated
- Published 2017-04-05
On 2017-04-05 the FDA classified a Class II recall of SynchroMed II implantable drug infusion pump, Model 8637-40 by Medtronic Neuromodulation, citing medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1694-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-09 |
| Published | 2017-04-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | IL |
Product
SynchroMed II implantable drug infusion pump, Model 8637-40,
Reason
Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted SynchroMed II pump. The error code prevented the physician from updating the pump; however the pump was providing therapy.
Identifiers
| code_info | Serial Number NGV526743H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1694-2017%22
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