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Medtronic Neuromodulation recalls Medtronic SynchroMed II, Model 8637-20, Programmable pump
Recalled January 3, 2024 · FDA recall Z-0614-2024 · Medtronic Neuromodulation
Hazard
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. · FDA Class II
Units
98311 units
Sold at
Worldwide
Description
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.
Product
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →