FDA-Device2024-01-03Class II
Medtronic SynchroMed II, Model 8637-20, Programmable pump
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.
Sold states
Worldwide
Affected count
98311 units
Manufactured in
7000 Central Ave Ne, Minneapolis, MN, United States
Products
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0614-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief