Medtronic SynchroMed II, Model 8637-20, Programmable pump
Reported: January 3, 2024 Initiated: November 13, 2023 #Z-0614-2024
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 98311 units
- Distribution
- Worldwide
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic SynchroMed II, Model 8637-20, Programmable pump. Recalled by Medtronic Neuromodulation. Units affected: 98311 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 3, 2024. Severity: Moderate. Recall number: Z-0614-2024.
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