--- title: "Medtronic SynchroMed II, Model 8637-20, Programmable pump — FDA record Z-0614-2024 | Is It on Recall" description: "Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the" url: https://isitonrecall.com/recall/fda-device-z-0614-2024-medtronic-synchromed-ii-model-8637-20-programmable-pump/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Medtronic SynchroMed II, Model 8637-20, Programmable pump — FDA record Z-0614-2024 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Nov 13, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Medtronic SynchroMed II, Model 8637-20, Programmable pump - **Reason**: 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. - **Classification**: Class II - **Recalling firm**: Medtronic Neuromodulation - **Quantity**: 98311 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0614-2024 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0614-2024%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | GTIN 00613994518781, Serial Numbers: NGP756746H, NGP000266H, NGP000270H, NGP000273H, NGP000274H, NGP000276H, NGP000292H, NGP000293H, NGP000312H, NGP000513H, NGP000515H, NGP000516H, NGP000589H, NGP000591H, NGP000592H, NGP000595H, NGP000596H, NGP000597H, NGP000598H, NGP000599H, NGP000600H, NGP000601H, NGP000602H, NGP000603H, NGP000604H, NGP000605H, NGP000606H, NGP000607H, NGP001428H, NGP001466H, NGP001467H, NGP001469H, NGP001471H, NGP001472H, NGP001473H, NGP001475H, NGP001476H, NGP001477H, NGP001479H, NGP001480H, NGP001482H, NGP001483H, NGP001484H, NGP001485H, NGP001487H, NGP001488H, NGP001489H, NGP001490H, NGP001491H, NGP001492H, NGP001493H, NGP001494H, NGP001495H, NGP001496H, NGP001498H, NGP001499H, NGP001500H, NGP001501H, NGP001502H, NGP001684H, NGP001685H, NGP001686H, NGP001688H, NGP001689H, NGP001692H, NGP001695H, NGP001696H, NGP001697H, NGP001698H, NGP001699H, NGP001700H, NGP001701H, NGP001703H, NGP001704H, NGP001705H, NGP001706H, NGP001707H, NGP001708H, NGP003370H, NGP003371H, NGP003372H, NGP003374H, NGP003375H, NGP003376H, NGP003378H, NGP003379H, NGP003382H, NGP003383H, NGP003384H, NGP003385H, NGP003386H, NGP003387H, NGP003388H, NGP003389H, NGP003391H, NGP003392H, NGP003393H, NGP003394H, NGP003396H, NGP003397H, NGP003398H, NGP003399H, NGP003400H, NGP003401H, NGP003402H, NGP003403H, NGP003404H, NGP003405H, NGP003406H, NGP003407H, NGP003408H, NGP003409H, NGP004884H, NGP004885H, NGP004886H, NGP004887H, NGP004888H, NGP004889H, NGP004890H, NGP004891H, NGP004892H, NGP004893H, NGP004894H, NGP004895H, NGP004896H, NGP004899H, NGP004900H, NGP004905H, NGP004906H, NGP004912H, NGP004913H, NGP004916H, NGP004919H, NGP004924H, NGP004925H, NGP004926H, NGP004968H, NGP004969H, NGP004971H, NGP004973H, NGP004975H, NGP004976H, NGP004977H, NGP004978H, NGP004979H, NGP004980H, NGP004983H, NGP004984H, NGP004986H, NGP004987H, NGP004991H, NGP005000H, NGP005001H, NGP005003H, NGP005004H, NGP005005H, NGP005006H, NGP005007H, NGP005009H, NGP005010H, NGP005011H, NGP005012H, NGP005013H, NGP005014H, NGP005016H, NGP412982H, NGP412983H, NGP412984H, NGP412988H, NGP412991H, NGP412992H, NGP412996H, NGP412999H, NGP413002H, NGP413009H, NGP413015H, NGP413018H, NGP413028H, NGP413032H, NGP413038H, NGP413062H, NGP413065H, NGP413066H, NGP413217H, NGP413218H, NGP413238H, NGP413276H, NGP413284H, NGP413289H, NGP413290H, NGP413291H, NGP413328H, NGP413364H, NGP413384H, NGP413393H, NGP413396H, NGP413410H, NGP413419H, NGP413420H, NGP413448H, NGP413454H, NGP413477H, NGP413486H, NGP413534H, NGP413568H, NGP413819H, NGP413822H, NGP413844H, NGP413846H, NGP414041H, NGP414078H, NGP414117H, NGP414152H, NGP414391H, NGP414405H, NGP414546H, NGP414547H, NGP414549H, NGP414550H, NGP414551H, NGP414553H, NGP414555H, NGP414559H, NGP414560H, NGP414562H, NGP414565H, NGP414571H, NGP414572H, NGP414573H, NGP414574H, NGP414575H, NGP414580H, NGP414581H, NGP414582H, NGP414583H, NGP414634H, NGP414745H, NGP414842H, NGP415128H, NGP415130H, NGP415131H, NGP415133H, NGP415134H, NGP415135H, NGP415136H, NGP415137H, NGP415139H, NGP415143H, NGP415144H, NGP415146H, NGP415147H, NGP415148H, NGP415149H, NGP415150H, NGP415151H, NGP415152H, NGP415153H, NGP415673H, NGP415674H, NGP416897H, NGP417710H, NGP417711H, NGP417712H, NGP417714H, NGP417715H, NGP417717H, NGP417719H, NGP417721H, NGP417744H, NGP417745H, NGP417746H, NGP417747H, NGP417748H, NGP417749H, NGP417750H, NGP417751H, NGP417752H, NGP417753H, NGP417754H, NGP417755H, NGP417756H, NGP417757H, NGP417758H, NGP417759H, NGP417760H, NGP417761H, NGP417762H, NGP417763H, NGP418733H, NGP418735H, NGP418736H, NGP418737H, NGP418738H, NGP418739H, NGP418740H, NGP418741H, NGP418742H, NGP418743H, NGP418744H, NGP418745H, NGP418746H, NGP418748H, NGP418749H, NGP418750H, NGP418751H, NGP418752H, NGP418753H, NGP419605H, NGP419606H, NGP419607H, NGP419608H, NGP419609H, NGP419610H, NGP419611H, NGP419614H, NGP419615H, NGP419616H, NGP419617H, NGP419619H, NGP419620H, NGP419621H, NGP419622H, NGP419623H, NGP420910H, NGP420913H, NGP420918H, NGP420919H, NGP420920H, NGP420924H, NGP420925H, NGP420930H, NGP420931H, NGP421034H, NGP421050H, NGP421079H, NGP421116H, NGP421137H, NGP421138H, NGP421140H, NGP421144H, NGP421145H, NGP421150H, NGP421153H, NGP421160H, NGP421162H, NGP421167H, NGP421168H, NGP421180H, NGP421181H, NGP421183H, NGP421184H, NGP422047H, NGP422719H, NGP422720H, NGP422722H, NGP422725H, NGP422727H, NGP422728H, NGP422730H, NGP422732H, NGP422733H, NGP422735H, NGP422737H, NGP422739H, NGP422740H, NGP422743H, NGP422745H, NGP422746H, NGP422747H, NGP424043H, NGP424044H, NGP424046H, NGP424053H, NGP424061H, NGP424065H, NGP424067H, NGP424072H, NGP424078H, NGP424083H, NGP424086H, NGP424087H, NGP424088H, NGP424099H, NGP424100H, NGP424101H, NGP425210H, NGP425213H, NGP425217H, NGP425220H, NGP425848H, NGP425849H, NGP425850H, NGP425851H, NGP425852H, NGP425853H, NGP425854H, NGP425855H, NGP425856H, NGP425857H, NGP425858H, NGP425859H, NGP425860H, NGP425861H, NGP425862H, NGP425863H, NGP425864H, NGP425865H, NGP425866H, NGP425867H, NGP426800H, NGP426801H, NGP426803H, NGP426806H, NGP426807H, NGP426808H, NGP426809H, NGP426810H, NGP426811H, NGP426812H, NGP426813H, NGP426814H, NGP426816H, NGP426817H, NGP426818H, NGP426819H, NGP426821H, NGP426823H, NGP426825H, NGP426826H, NGP427469H, NGP427470H, NGP427471H, NGP427472H, NGP427474H, NGP427479H, NGP427482H, NGP427483H, NGP427484H, NGP427492H, NGP427494H, NGP427503H, NGP427504H, NGP427505H, NGP427508H, NGP427510H, NGP427511H, NGP427512H, NGP427517H, NGP427521H, NGP427523H, NGP427524H, NGP427525H, NGP427526H, NGP427528H, NGP427529H, NGP427530H, NGP427531H, NGP427532H, NGP427533H, NGP427534H, NGP427535H, NGP427538H, NGP427539H, NGP427540H, NGP427542H, NGP427543H, NGP427546H, NGP427547H, NGP427548H, NGP427551H, NGP427552H, NGP427553H, NGP427555H, NGP427556H, NGP427657H, NGP427660H, NGP427661H, NGP427664H, NGP427665H, NGP427669H, NGP427670H, NGP427671H, NGP427672H, NGP427673H, NGP427674H, NGP427676H, NGP427677H, NGP427678H, NGP427679H, NGP427682H, NGP427683H, NGP427684H, NGP427685H, NGP427687H, NGP427688H, NGP427690H, NGP427691H, NGP427692H, NGP427693H, NGP427694H, NGP427696H, NGP427697H, NGP427698H, NGP427699H, NGP427700H, NGP427701H, NGP427702H, NGP427703H, NGP427704H, NGP427705H, NGP427706H, NGP427707H, NGP427708H, NGP427709H, NGP427710H, NGP427711H, NGP427712H, NGP427713H, NGP427716H, NGP427717H, NGP427718H, NGP427720H, NGP427721H, NGP427723H, NGP427724H, NGP427726H, NGP427727H, NGP427728H, NGP427730H, NGP429304H, NGP429307H, NGP429308H, NGP429316H, NGP429317H, NGP429324H, NGP429328H, NGP429331H, NGP429333H, NGP429335H, NGP429339H, NGP429342H, NGP429343H, NGP429345H, NGP429346H, NGP429347H, NGP429350H, NGP429354H, NGP429355H, NGP429357H, NGP429362H, NGP431580H, NGP431582H, NGP431584H, NGP431586H, NGP431588H, NGP431589H, NGP431590H, NGP431591H, NGP431592H, NGP431599H, NGP431603H, NGP431605H, NGP431607H, NGP431610H, NGP431614H, NGP431615H, NGP431616H, NGP431618H, NGP431620H, NGP431621H, NGP431622H, NGP431624H, NGP431629H, NGP431631H, NGP432117H, NGP432130H, NGP432134H, NGP432136H, NGP432138H, NGP432142H, NGP432144H, NGP432147H, NGP432148H, NGP432150H, NGP432502H, NGP432539H, NGP432540H, NGP432541H, NGP432542H, NGP432543H, NGP432544H, NGP432545H, NGP432546H, NGP432547H, NGP432549H, NGP432550H, NGP432551H, NGP432552H, NGP432553H, NGP432554H, NGP432555H, NGP432556H, NGP432557H, NGP432558H, NGP432559H, NGP432560H, NGP432561H, NGP432562H, NGP432642H, NGP432976H, NGP433114H, NGP433115H, NGP433116H, NGP433117H, NGP433120H, NGP433121H, NGP433122H, NGP433223H, NGP433225H, NGP433226H, NGP433228H, NGP433231H, NGP433232H, NGP434066H, NGP434574H, NGP434575H, NGP434576H, NGP434577H, NGP434578H, NGP434579H, NGP434580H, NGP434581H, NGP434584H, NGP434879H, NGP434880H, NGP434881H, NGP434882H, NGP434886H, NGP434889H, NGP434893H, NGP434894H, NGP434908H, NGP434913H, NGP434915H, NGP434916H, NGP434918H, NGP434927H, NGP434928H, NGP434929H, NGP434930H, NGP434931H, NGP434932H, NGP434933H, NGP434935H, NGP434936H, NGP434948H, NGP434959H, NGP434960H, NGP434961H, NGP434965H, NGP434971H, NGP434972H, NGP435681H, NGP435682H, NGP435683H, NGP435684H, NGP435685H, NGP435686H, NGP435687H, NGP435688H, NGP435689H, NGP435690H, NGP435691H, NGP435692H, NGP435693H, NGP435695H, NGP435697H, NGP435699H, NGP435700H, NGP435702H, NGP435705H, NGP435706H, NGP435708H, NGP435709H, NGP435710H, NGP435712H, NGP435714H, NGP435716H, NGP435717H, NGP435718H, NGP435719H, NGP435720H, NGP435721H, NGP435723H, NGP435724H, NGP436761H, NGP436768H, NGP436769H, NGP436776H, NGP436777H, NGP436781H, NGP436784H, NGP436787H, NGP436789H, NGP436791H, NGP436795H, NGP436796H, NGP436797H, NGP436798H, NGP436800H, NGP436801H, NGP436802H, NGP436803H, NGP436804H, NGP436805H, NGP437225H, NGP437227H, NGP437228H, NGP437229H, NGP437230H, NGP437232H, NGP437233H, NGP437234H, NGP437235H, NGP437236H, NGP437237H, NGP437239H, NGP437240H, NGP437241H, NGP437242H, NGP437243H, NGP437244H, NGP437245H, NGP437246H, NGP439814H, NGP439817H, NGP439821H, NGP439824H, NGP439830H, NGP439832H, NGP439833H, NGP439834H, NGP439841H, NGP439844H, NGP439847H, NGP439848H, NGP439849H, NGP439851H, NGP439855H, NGP439858H, NGP439860H, NGP439861H, NGP439862H, NGP439863H, NGP439865H, NGP439867H, NGP439868H, NGP439869H, NGP441082H, NGP441083H, NGP441084H, NGP441085H, NGP441086H, NGP441088H, NGP441089H, NGP441090H, NGP441091H, NGP441092H, NGP441094H, NGP441095H, NGP441096H, NGP441097H, NGP441098H, NGP441101H, NGP441106H, NGP441109H, NGP441110H, NGP441111H, NGP441112H, NGP441115H, NGP441117H, NGP441739H, NGP441740H, NGP441742H, NGP441743H, NGP441747H, NGP441748H, NGP441749H, NGP441754H, NGP441755H, NGP441756H, NGP441757H, NGP441758H, NGP441759H, NGP441760H, NGP441761H, NGP441762H, NGP441763H, NGP441764H, NGP441765H, NGP441766H, NGP441769H, NGP441770H, NGP442698H, NGP442700H, NGP442702H, NGP442703H, NGP442704H, NGP442706H, NGP442707H, NGP442750H, NGP442753H, NGP442754H, NGP442755H, NGP442757H, NGP442758H, NGP442761H, NGP442762H, NGP442766H, NGP442768H, NGP442777H, NGP442779H, NGP442782H, NGP442785H, NGP442786H, NGP442791H, NGP442792H, NGP442795H, NGP443492H, NGP443493H, NGP443495H, NGP443496H, NGP443497H, NGP443498H, NGP443499H, NGP443500H, NGP443503H, NGP443657H, NGP443933H, NGP443934H, NGP443935H, NGP443937H, NGP443938H, NGP443939H, NGP443940H, NGP443941H, NGP443942H, NGP443943H, NGP443944H, NGP443945H, NGP443946H, NGP443947H, NGP443948H, NGP443951H, NGP443952H, NGP443953H, NGP443954H, NGP444872H, NGP444873H, NGP444874H, NGP444876H, NGP444877H, NGP444878H, NGP444879H, NGP444880H, NGP444881H, NGP444882H, NGP444883H, NGP444884H, NGP444886H, NGP444887H, NGP444888H, NGP444889H, NGP444890H, NGP444891H, NGP444893H, NGP444895H, NGP444896H, NGP444897H, NGP444898H, NGP444900H, NGP444901H, NGP444903H, NGP444904H, NGP445234H, NGP445594H, NGP445595H, NGP445596H, NGP445597H, NGP445598H, NGP445599H, NGP445600H, NGP445601H, NGP445602H, NGP445603H, NGP445604H, NGP445605H, NGP445606H, NGP445610H, NGP445611H, NGP446941H, NGP446942H, NGP446943H, NGP446946H, NGP446949H, NGP446950H, NGP446952H, NGP446953H, NGP446955H, NGP446958H, NGP447659H, NGP447661H, NGP447662H, NGP447663H, NGP447664H, NGP447665H, NGP447666H, NGP447667H, NGP447668H, NGP447669H, NGP447670H, NGP447671H, NGP447672H, NGP447673H, NGP447674H, NGP447676H, NGP447677H, NGP447678H, NGP447680H, NGP447682H, NGP447683H, NGP447684H, NGP447686H, NGP447687H, NGP447688H, NGP447689H, NGP447690H, NGP447691H, NGP447692H, NGP447693H, NGP447694H, NGP447833H, NGP447846H, NGP447848H, NGP447849H, NGP447850H, NGP447851H, NGP447852H, NGP447853H, NGP447863H, NGP447865H, NGP447870H, NGP447871H, NGP448061H, NGP448063H, NGP448064H, NGP448065H, NGP448066H, NGP448067H, NGP448070H, NGP448071H, NGP448073H, NGP448074H, NGP448076H, NGP448079H, NGP448080H, NGP448084H, NGP448085H, NGP448087H, NGP448094H, NGP448095H, NGP448111H, NGP448112H, NGP448114H, NGP448123H, NGP600403H, NGP600404H, NGP600405H, NGP600406H, NGP600407H, NGP600409H, NGP600410H, NGP600411H, NGP600412H, NGP600413H, NGP600414H, NGP600415H, NGP600416H, NGP600417H, NGP600418H, NGP600419H, NGP600420H, NGP600421H, NGP600422H, NGP600424H, NGP600425H, NGP60042... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0614-2024%22). Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide No US distribution state could be established from this record. Check the official notice. ## Dates in the source - **Report date**: Jan 3, 2024 - **Recall initiation date**: Nov 13, 2023 - **Center classification date**: Dec 22, 2023 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0614-2024%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Neuromodulation records](https://isitonrecall.com/brand/medtronic-neuromodulation/)