Class II

Medical Device Recall: Medtronic SynchroMed II, Model 8637-20, Programmable pump

Medtronic Neuromodulation · November 13, 2023

Reason for Recall

Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.

Distribution

Worldwide

Quantity Affected

98311 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0614-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.