Reported Jan 3, 2024 · Ongoing
Medtronic SynchroMed II, Model 8637-40, 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 8637-40, Programmable pump
- Lot codes and dates
- GTIN 00613994483195
- Serial Numbers
NGV502657HNGV508302HNGV612281HNGV612282HNGV717221HNGV723564HNGV727392HNGV727397HNGV727400HNGV727906HNGV730310HNGV741180HGTIN 00643169100824
- Serial Numbers
1,787 of 1,787 codes
NGV503518HNGV503522HNGV504577HNGV504580HNGV504581HNGV507269HNGV507271HNGV507272HNGV507273HNGV507431HNGV507433HNGV507434HNGV507436HNGV508247HNGV508248HNGV508257HNGV509489HNGV509490HNGV510082HNGV512179HNGV512180HNGV502833HNGV503294HNGV502489HNGV511809HNGV510811HNGV507369HNGV511074HNGV512393HNGV502490HNGV509057HNGV506230HNGV503295HNGV507614HNGV509098HNGV509769HNGV503297HNGV502903HNGV504121HNGV511164HNGV512019HNGV502487HNGV504523HNGV503292HNGV511885HNGV511163HNGV509373HNGV502488HNGV506232HNGV510872HNGV509770HNGV510474HNGV512471HNGV508053HNGV504241HNGV507628HNGV507635HNGV503352HNGV512033HNGV512037H
- Serial Numbers
815 of 815 codes
NGV502310HNGV503261HNGV512927HNGV501842HNGV503108HNGV502325HNGV503314HNGV503794HNGV503795HNGV503796HNGV503266HNGV506020HNGV509254HNGV503149HNGV512049HNGV512290HNGV512511HNGV512890HNGV502315HNGV510144HNGV512906HNGV503151HNGV503747HNGV508188HNGV503733HNGV505517HNGV505867HNGV508004HNGV508011HNGV508022HNGV508205HNGV508255HNGV509209HNGV509226HNGV509688HNGV509970HNGV512884HNGV503150HNGV504463HNGV500935HNGV505087HNGV505162HNGV505163HNGV509238HNGV509575HNGV509817HNGV510140HNGV511496HNGV501906HNGV506490HNGV507930HNGV512897HNGV505543HNGV506470HNGV502120HNGV508488HNGV509156HNGV511511HNGV513179HNGV503720H
- Serial Numbers
92 of 92 codes
NGV505552HNGV503213HNGV505677HNGV507449HNGV507450HNGV509444HNGV504407HNGV505179HNGV505660HNGV505891HNGV506448HNGV507065HNGV507372HNGV507918HNGV507941HNGV507964HNGV508071HNGV510789HNGV510935HNGV511866HNGV512710HNGV503755HNGV503776HNGV505686HNGV501512HNGV502393HNGV503671HNGV505100HNGV505110HNGV506999HNGV507022HNGV507920HNGV508327HNGV508475HNGV510786HNGV510944HNGV511869HNGV503818HNGV505299HNGV505448HNGV505538HNGV505555HNGV505687HNGV506022HNGV506979HNGV507440HNGV509194HNGV509214HNGV509236HNGV510156HNGV510229HNGV510939HNGV511613HNGV511705HNGV511916HNGV511921HNGV512005HNGV512062HNGV512527HNGV512748H
- Amount recalled
- 78532 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.
Want the full recall guide?
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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