Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic SynchroMed II Recalled by Medtronic Neuromodulation Due to Medtronic recently identified that if the SynchroMed II...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Neuromodulation directly.
Affected Products
Medtronic SynchroMed II, Model 8637-40, Programmable pump
Quantity: 78532 units
Why Was This 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.
Where Was This Sold?
Worldwide
About Medtronic Neuromodulation
Medtronic Neuromodulation has 95 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report