Official recall record
Medtronic SynchroMed II, Model 8637-40, Programmable pump
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-11-13
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00613994483195
- Brand on record
- Medtronic Neuromodulation
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-04-08 · US FDA — Medical Devices
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the follow - 2025-11-20 · US FDA — Medical Devices
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A - 2025-04-03 · US FDA — Medical Devices
Enhanced Verify Evaluation Handset (CFN HH90130FA)
All 6 official recall notices naming Medtronic Neuromodulation on this site →
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