CLASS II ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report
SynchroMed II Infusion Pump recalled by Medtronic Neuromodulation
Medtronic Neuromodulation is recalling SynchroMed II Infusion Pump, distributed nationwide in the US. The recall was initiated on 11 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0137-2025
- FDA event ID
- 95419
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Sep 2024
- FDA classified
- 21 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Infusion Pumps
Timeline
| 11 Sep 2024 | Recall initiated by company | |
| 21 Oct 2024 | Classified by FDA | +40 days |
| 30 Oct 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Product as listed by the FDA
SynchroMed II Infusion Pump. Product Number: 8637-20
Where it was distributed
US Nationwide distribution in the state of Mississippi.
Questions about this recall
Why was it recalled?
Potential for error and inability to interrogate pump due to data corruption in the pump memory.
Which lots are affected?
GTIN Number: 00643169630505. Serial Number: NGP004814H
Where was it sold?
US Nationwide distribution in the state of Mississippi.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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