FDA Device recall Z-0508-2020
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
- FDA Device
- Class I
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class I recall of Synchromed II programmable pump, Model numbers 8637-20 and 8637-40 by Medtronic Neuromodulation, citing there is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0508-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-10-11 |
| Published | 2019-12-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | n/a |
Product
Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Reason
There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.
Identifiers
| code_info | Product Number 8637-20 Serial Numbers: NGP000003H NGP000008H NGP000009H NGP000011H NGP000013H NGP000014H NGP000…Product Number 8637-20 Serial Numbers: NGP000003H NGP000008H NGP000009H NGP000011H NGP000013H NGP000014H NGP000017H NGP000018H NGP000019H NGP000020H NGP000023H NGP000024H NGP000026H NGP000027H NGP000029H NGP000031H NGP000032H NGP000033H NGP000034H NGP000035H NGP000036H NGP000037H NGP000038H NGP000039H NGP000040H NGP000046H NGP000048H NGP000071H NGP000076H NGP000086H NGP000106H NGP000107H NGP000111H NGP000119H NGP000128H NGP000138H NGP000142H NGP000143H NGP000145H NGP000150H NGP000159H NGP000160H NGP000163H NGP000176H NGP000178H NGP000184H NGP000197H NGP000198H NGP000199H NGP000204H NGP000242H NGP000245H NGP000249H NGP000251H NGP000252H NGP000253H NGP000254H NGP000255H NGP000256H NGP000257H NGP000258H NGP000261H NGP000269H NGP000270H NGP000274H NGP000276H NGP000278H NGP000281H NGP000282H NGP000290H NGP000293H NGP000295H NGP000296H NGP000299H NGP000300H NGP000303H NGP000304H NGP000308H NGP000311H NGP000313H |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0508-2020%22
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