Reported Jan 3, 2024 · Ongoing
Medtronic SynchroMed II, Model 8637-20, Programmable pump
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- Medtronic SynchroMed II, Model 8637-20, Programmable pump
- Lot codes and dates
- GTIN 00613994518781
- Serial Numbers
2,714 of 2,714 codes
NGP756746HNGP000266HNGP000270HNGP000273HNGP000274HNGP000276HNGP000292HNGP000293HNGP000312HNGP000513HNGP000515HNGP000516HNGP000589HNGP000591HNGP000592HNGP000595HNGP000596HNGP000597HNGP000598HNGP000599HNGP000600HNGP000601HNGP000602HNGP000603HNGP000604HNGP000605HNGP000606HNGP000607HNGP001428HNGP001466HNGP001467HNGP001469HNGP001471HNGP001472HNGP001473HNGP001475HNGP001476HNGP001477HNGP001479HNGP001480HNGP001482HNGP001483HNGP001484HNGP001485HNGP001487HNGP001488HNGP001489HNGP001490HNGP001491HNGP001492HNGP001493HNGP001494HNGP001495HNGP001496HNGP001498HNGP001499HNGP001500HNGP001501HNGP001502HNGP001684H
- Amount recalled
- 98311 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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