FDA recall Z-0614-2024

Product

Medtronic SynchroMed II, Model 8637-20, Programmable pump

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

Key facts

Status

Ongoing

Initiation date

2023-11-13

Report date

2024-01-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0614-2024