Recall Z-0614-2024— Medtronic Neuromodulation
Class II · Ongoing
Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2023-11-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic SynchroMed II, Model 8637-20, Programmable pump. Reason: 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..
- Recalling firm
- Medtronic Neuromodulation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-11-13
- Firm location
- Minneapolis, MN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.