Medical device recalls Moderate risk

Medtronic Neuromodulation recalls SynchroMed II Infusion Pump. Product Number: 8637-20

Recall date
September 11, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0137-2025
FDA classification
Class II
Brand / firm
Medtronic Neuromodulation
Sold / distributed
US Nationwide distribution in the state of Mississippi.

Why it was recalled

Potential for error and inability to interrogate pump due to data corruption in the pump memory.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SynchroMed II Infusion Pump. Product Number: 8637-20

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