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Recall Observatory FDA recall evidence

Device product

SynchroMed II Infusion Pump. Product Number: 8637-20

Z-0137-2025

September 11, 2024

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 95419
Status
Ongoing
Classification
Class II
Quantity
1 unit
Official record key
device-enforcement:Z-0137-2025

Official wording

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

Code information: GTIN Number: 00643169630505. Serial Number: NGP004814H

Distribution pattern: US Nationwide distribution in the state of Mississippi.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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