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. Source coverage and dates.

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

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityGTIN 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.

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.

Related records