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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic SynchroMed II Implantable Infusion Pumps

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  Class 2 Device Recall Medtronic SynchroMed II Implantable Infusion Pumps see related information
Date Initiated by Firm April 10, 2015
Date Posted May 28, 2015
Recall Status1 Terminated 3 on November 23, 2015
Recall Number Z-1681-2015
Recall Event ID 71047
PMA Number P860004 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
Product Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile.

Product Usage:
The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter
Code Information US Serial Number NGP411628H NGP411629H NGP411685H NGP411704H NGP411801H NGV501193H NGP410146H NGP410147H NGP410148H NGP410149H NGP410151H NGP410153H NGP410156H NGP410160H NGP410162H NGP410163H NGP410169H NGP410171H NGP410175H NGP410177H NGP410178H NGP410179H NGP410181H NGP410182H NGP410183H NGP410184H NGP410186H NGP410188H NGP410189H NGP410190H NGP410191H NGP410196H NGP410197H NGP410198H NGP410200H NGP410201H NGP410204H NGP410206H NGP410213H NGP410215H NGP410216H NGP410217H NGP410219H NGP410220H NGP410221H NGP410223H NGP410230H NGP410231H NGP410233H NGP410234H NGP410237H NGP410240H NGP410241H NGP410244H NGP410950H NGP410956H NGP410964H NGP410968H NGP410969H NGP410970H NGP410976H NGP410978H NGP410979H NGP410982H NGP410989H NGP410992H NGP411000H NGP411009H NGP411012H NGP411015H NGP411017H NGP411018H NGP411042H NGP411047H NGP411052H NGP411053H NGP411056H NGP411062H NGP411063H NGP411064H NGP411065H NGP411070H NGP411083H NGP411084H NGP411087H NGP411091H NGP411096H NGP411100H NGP411104H NGP411105H NGP411107H NGP411117H NGP411118H NGP411123H NGP411127H NGP411128H NGP411136H NGP411146H NGP411147H NGP411149H NGP411154H NGP411157H NGP411162H NGP411164H NGP411169H NGP411171H NGP411176H NGP411187H NGP411191H NGP411197H NGP411202H NGP411204H NGP411205H NGP411208H NGP411209H NGP411212H NGP411214H NGP411216H NGP411217H NGP411219H NGP411221H NGP411225H NGP411227H NGP411228H NGP411233H NGP411234H NGP411237H NGP411238H NGP411242H NGP411243H NGP411245H NGP411247H NGP411249H NGP411252H NGP411255H NGP411256H NGP411258H NGP411259H NGP411261H NGP411263H NGP411266H NGP411267H NGP411268H NGP411271H NGP411274H NGP411277H NGP411282H NGP411283H NGP411289H NGP411290H NGP411291H NGP411293H NGP411299H NGP411310H NGP411314H NGP411315H NGP411319H NGP411334H NGP411342H NGP411347H NGP411355H NGP411356H NGP411363H NGP411482H NGP411484H NGP411488H NGP411489H NGP411491H NGP411492H NGP411493H NGP411494H NGP411495H NGP411496H NGP411498H NGP411500H NGP411501H NGP411503H NGP411505H NGP411506H NGP411507H NGP411511H NGP411513H NGP411514H NGP411515H NGP411516H NGP411517H NGP411520H NGP411521H NGP411522H NGP411523H NGP411524H NGP411525H NGP411527H NGP411529H NGP411530H NGP411531H NGP411532H NGP411533H NGP411534H NGP411535H NGP411536H NGP411537H NGP411538H NGP411539H NGP411540H NGP411542H NGP411543H NGP411546H NGP411547H NGP411548H NGP411549H NGP411551H NGP411557H NGP411560H NGP411565H NGP411567H NGP411568H NGP411569H NGP411570H NGP411574H NGP411576H NGP411577H NGP411578H NGP411579H NGP411582H NGP411583H NGP411590H NGP411592H NGP411593H NGP411595H NGP411596H NGP411597H NGP411598H NGP411601H NGP411602H NGP411603H NGP411607H NGP411611H NGP411612H NGP411613H NGP411614H NGP411615H NGP411616H NGP411617H NGP411622H NGP411623H NGP411625H NGP411626H NGP411627H NGP411631H NGP411635H NGP411636H NGP411648H NGP411651H NGP411655H NGP411656H NGP411657H NGP411658H NGP411661H NGP411662H NGP411663H NGP411664H NGP411665H NGP411666H NGP411667H NGP411670H NGP411672H NGP411677H NGP411679H NGP411680H NGP411686H NGP411688H NGP411690H NGP411693H NGP411696H NGP411698H NGP411699H NGP411700H NGP411701H NGP411702H NGP411706H NGP411708H NGP411709H NGP411710H NGP411713H NGP411716H NGP411720H NGP411721H NGP411722H NGP411723H NGP411724H NGP411725H NGP411726H NGP411727H NGP411729H NGP411730H NGP411731H NGP411732H NGP411733H NGP411735H NGP411738H NGP411739H NGP411740H NGP411741H NGP411742H NGP411744H NGP411745H NGP411747H NGP411749H NGP411753H NGP411757H NGP411758H NGP411760H NGP411763H NGP411766H NGP411768H NGP411769H NGP411771H NGP411773H NGP411774H NGP411776H NGP411777H NGP411780H NGP411781H NGP411783H NGP411785H NGP411787H NGP411795H NGP411797H NGP411798H NGP411799H NGP411802H NGP411804H NGP411805H NGP411806H NGP411807H NGP411808H NGP411809H NGP411810H NGP411811H NGP411813H NGP411815H NGP411818H NGP411820H NGP411823H NGP411824H NGP411826H NGP411827H NGP411828H NGP411832H NGP411833H NGP411834H NGP411837H NGP411845H NGP411846H NGP411847H NGP411853H NGP411860H NGP411862H NGP411864H NGP411865H NGP411870H NGP411872H NGP411874H NGP411875H NGP411877H NGP411878H NGP411881H NGP411883H NGP411885H NGP411888H NGP411892H NGP411894H NGP411895H NGP411896H NGP411898H NGP411902H NGP411907H NGP411908H NGP411909H NGP411910H NGP411911H NGP411915H NGP411917H NGP411919H NGP411920H NGP411927H NGP411928H NGP411929H NGP411932H NGP411937H NGP411944H NGP411945H NGP411946H NGP411949H NGP411952H NGP411954H NGP411955H NGP411956H NGP411957H NGP411962H NGP411964H NGP411965H NGP411967H NGP411968H NGP411969H NGP411970H NGP411971H NGP411974H NGP411983H NGP412000H NGP412004H NGP412009H NGP412014H NGP412020H NGP412029H NGP412045H NGP412046H NGP412072H NGP412073H NGP412075H NGP412079H NGP412080H NGP412081H NGP412083H NGP412084H NGP412088H NGP412090H NGP412091H NGP412095H NGP412096H NGP412097H NGP412098H NGP412099H NGP412101H NGP412102H NGP412112H NGP412113H NGP412116H NGP412118H NGP412123H NGP412125H NGP412126H NGP412128H NGP412130H NGP412131H NGP412133H NGP412134H NGP412135H NGP412139H NGP412141H NGP412142H NGP412143H NGP412145H NGP412146H NGP412147H NGP412149H NGP412151H NGP412152H NGP412153H NGP412154H NGP412159H NGP412161H NGP412162H NGP412163H NGP412164H NGP412167H NGP412168H NGP412170H NGP412173H NGP412175H NGP412178H NGP412179H NGP412180H NGP412181H NGP412182H NGP412184H NGP412185H NGP412186H NGP412193H NGP412196H NGP412197H NGP412198H NGP412199H NGP412200H NGP412201H NGP412203H NGP412205H NGP412208H NGP412209H NGP412210H NGP412214H NGP412216H NGP412218H NGP412219H NGP412220H NGP412222H NGP412224H NGP412226H NGP412227H NGP412228H NGP412229H NGP412230H NGP412232H NGP412233H NGP412234H NGP412236H NGP412237H NGP412239H NGP412243H NGP412244H NGP412245H NGP412246H NGP412247H NGP412248H NGP412249H NGP412252H NGP412253H NGP412254H NGP412255H NGP412256H NGP412257H NGP412258H NGP412260H NGP412262H NGP412263H NGP412264H NGP412270H NGP412272H NGP412273H NGP412274H NGP412275H NGP412278H NGP412280H NGP412281H NGP412282H NGP412284H NGP412293H NGP412295H NGP412296H NGP412298H NGP412299H NGP412305H NGP412307H NGP412309H NGP412310H NGP412311H NGP412313H NGP412314H NGP412317H NGP412318H NGP412320H NGP412321H NGP412322H NGP412323H NGP412325H NGP412328H NGP412330H NGP412331H NGP412332H NGP412333H NGP412334H NGP412336H NGP412338H NGP412339H NGP412340H NGP412341H NGP412344H NGP412345H NGP412347H NGP412348H NGP412349H NGP412350H NGP412351H NGP412352H NGP412353H NGP412355H NGP412358H NGP412359H NGP412360H NGP412361H NGP412362H NGP412363H NGP412367H NGP412368H NGP412411H NGP412455H NGP412472H NGP412477H NGP412480H NGP412483H NGP412484H NGP412489H NGP412500H NGP412507H NGP412511H NGP412513H NGP412517H NGP412521H NGP412524H NGP412526H NGP412527H NGP412532H NGP412535H NGP412542H NGP412546H NGP412548H NGP412553H NGP412571H NGP412604H NGP412613H NGP412645H NGP412647H NGP412671H NGP412678H NGP412682H NGP412700H NGP412707H NGP412717H NGP412719H NGP412722H NGP412725H NGP412738H NGP412739H NGP412740H NGP412746H NGP412749H NGP412756H NGP412770H NGP412772H NGP412789H NGP412794H NGP412798H NGP412800H NGP412802H NGP412833H NGP412836H NGP412838H NGP412849H NGP412855H NGP412882H NGP412883H NGV497049H NGV497052H NGV497053H NGV497058H NGV497059H NGV497062H NGV497063H NGV497066H NGV497067H NGV497068H NGV497069H NGV497070H NGV497071H NGV497072H NGV497073H NGV497074H NGV497075H NGV497077H NGV497078H NGV497081H NGV497082H NGV497084H NGV497085H NGV497086H NGV497090H NGV497091H NGV497092H NGV497093H NGV497095H NGV497096H NGV497097H NGV497098H NGV497100H NGV497101H NGV497970H NGV497979H NGV497982H NGV497985H NGV497986H NGV497988H NGV497995H NGV497998H NGV498002H NGV498012H NGV498014H NGV498016H NGV498018H NGV498020H NGV498022H NGV498023H NGV498024H NGV498027H NGV498030H NGV498031H NGV498035H NGV498040H NGV498042H NGV498049H NGV498054H NGV498056H NGV498057H NGV498058H NGV498061H NGV498062H NGV498063H NGV498065H NGV498066H NGV498067H NGV498068H NGV499788H NGV499791H NGV499805H NGV499808H NGV499817H NGV499830H NGV499831H NGV499834H NGV499841H NGV499850H NGV499855H NGV499857H NGV499864H NGV499865H NGV499867H NGV499876H NGV499877H NGV499878H NGV499879H NGV499881H NGV499883H NGV499884H NGV499889H NGV499891H NGV499892H NGV499893H NGV499903H NGV499905H NGV499908H NGV499909H NGV499910H NGV499914H NGV499916H NGV499918H NGV499919H NGV499920H NGV499921H NGV499922H NGV499925H NGV499929H NGV499936H NGV499940H NGV499941H NGV499947H NGV499950H NGV499952H NGV499960H NGV499961H NGV499963H NGV499966H NGV499974H NGV499975H NGV499976H NGV499978H NGV499979H NGV499980H NGV499981H NGV499983H NGV499989H NGV500012H NGV500020H NGV500031H NGV500037H NGV500045H NGV500082H NGV500089H NGV500093H NGV500095H NGV500097H NGV500102H NGV500105H NGV500106H NGV500107H NGV500108H NGV500109H NGV500111H NGV500112H NGV500114H NGV500117H NGV500118H NGV500119H NGV500122H NGV500124H NGV500126H NGV500128H NGV500129H NGV500130H NGV500131H NGV500132H NGV500133H NGV500135H NGV500136H NGV500140H NGV500143H NGV500146H NGV500148H NGV500150H NGV500160H NGV500163H NGV500170H NGV500172H NGV500173H NGV500176H NGV500177H NGV500179H NGV500180H NGV500184H NGV500186H NGV500190H NGV500194H NGV500196H NGV500197H NGV500202H NGV500203H NGV500204H NGV500207H NGV500209H NGV500213H NGV500214H NGV500215H NGV500217H NGV500220H NGV500221H NGV500222H NGV500223H NGV500224H NGV500225H NGV500226H NGV500228H NGV500232H NGV500233H NGV500236H NGV500237H NGV500240H NGV500242H NGV500245H NGV500246H NGV500248H NGV500251H NGV500270H NGV500271H NGV500274H NGV500278H NGV500279H NGV500280H NGV500283H NGV500288H NGV500289H NGV500291H NGV500292H NGV500293H NGV500298H NGV500300H NGV500301H NGV500303H NGV500308H NGV500313H NGV500315H NGV500318H NGV500319H NGV500320H NGV500329H NGV500331H NGV500333H NGV500334H NGV500341H NGV500343H NGV500344H NGV500345H NGV500347H NGV500413H NGV500414H NGV500415H NGV500416H NGV500417H NGV500418H NGV500419H NGV500420H NGV500422H NGV500424H NGV500427H NGV500429H NGV500432H NGV500433H NGV500437H NGV500438H NGV500439H NGV500440H NGV500441H NGV500443H NGV500453H NGV500455H NGV500456H NGV500457H NGV500459H NGV500461H NGV500464H NGV500465H NGV500466H NGV500467H NGV500469H NGV500470H NGV500471H NGV500473H NGV500475H NGV500478H NGV500480H NGV500481H NGV500482H NGV500483H NGV500485H NGV500486H NGV500487H NGV500490H NGV500491H NGV500492H NGV500493H NGV500495H NGV500496H NGV500498H NGV500500H NGV500501H NGV500502H NGV500503H NGV500504H NGV500505H NGV500508H NGV500514H NGV500515H NGV500516H NGV500518H NGV500521H NGV500522H NGV500523H NGV500526H NGV500527H NGV500528H NGV500531H NGV500532H NGV500533H NGV500534H NGV500535H NGV500536H NGV500539H NGV500541H NGV500542H NGV500543H NGV500544H NGV500545H NGV500547H NGV500548H NGV500549H NGV500556H NGV500557H NGV500558H NGV500559H NGV500560H NGV500561H NGV500565H NGV500566H NGV500567H NGV500568H NGV500569H NGV500570H NGV500571H NGV500572H NGV500573H NGV500574H NGV500575H NGV500576H NGV500577H NGV500579H NGV500580H NGV500581H NGV500583H NGV500586H NGV500587H NGV500588H NGV500590H NGV500591H NGV500592H NGV500593H NGV500594H NGV500595H NGV500596H NGV500597H NGV500599H NGV500602H NGV500604H NGV500605H NGV500607H NGV500608H NGV500609H NGV500610H NGV500611H NGV500612H NGV500613H NGV500615H NGV500618H NGV500621H NGV500622H NGV500623H NGV500624H NGV500625H NGV500626H NGV500627H NGV500628H NGV500629H NGV500630H NGV500631H NGV500633H NGV500634H NGV500635H NGV500637H NGV500638H NGV500639H NGV500640H NGV500642H NGV500649H NGV500650H NGV500651H NGV500654H NGV500659H NGV500663H NGV500664H NGV500665H NGV500666H NGV500668H NGV500669H NGV500670H NGV500671H NGV500672H NGV500674H NGV500675H NGV500676H NGV500677H NGV500678H NGV500684H NGV500687H NGV500691H NGV500692H NGV500694H NGV500696H NGV500698H NGV500699H NGV500703H NGV500710H NGV500712H NGV500713H NGV500714H NGV500715H NGV500716H NGV500717H NGV500718H NGV500720H NGV500721H NGV500722H NGV500723H NGV500724H NGV500725H NGV500726H NGV500728H NGV500733H NGV500734H NGV500737H NGV500738H NGV500739H NGV500743H NGV500748H NGV500749H NGV500750H NGV500751H NGV500752H NGV500753H NGV500754H NGV500755H NGV500758H NGV500764H NGV500765H NGV500767H NGV500769H NGV500772H NGV500774H NGV500778H NGV500782H NGV500783H NGV500787H NGV500791H NGV500792H NGV500794H NGV500796H NGV500800H NGV500802H NGV500803H NGV500807H NGV500809H NGV500810H NGV500812H NGV500815H NGV500821H NGV500830H NGV500832H NGV500842H NGV500844H NGV500851H NGV500852H NGV500888H NGV500904H NGV500912H NGV501109H NGV501112H NGV501114H NGV501115H NGV501116H NGV501121H NGV501122H NGV501123H NGV501124H NGV501125H NGV501129H NGV501130H NGV501134H NGV501135H NGV501136H NGV501141H NGV501146H NGV501147H NGV501149H NGV501150H NGV501152H NGV501155H NGV501157H NGV501164H NGV501165H NGV501168H NGV501171H NGV501172H NGV501175H NGV501176H NGV501180H NGV501181H NGV501183H NGV501184H NGV501192H NGV501194H NGV501196H NGV501197H NGV501199H NGV501201H NGV501202H NGV501207H NGV501210H NGV501214H NGV501217H NGV501221H NGV501224H NGV501227H NGV501228H NGV501230H NGV501232H NGV501235H NGV501239H NGV501240H NGV501241H NGV501242H NGV501244H NGV501245H NGV501246H NGV501247H NGV501249H NGV501250H NGV501251H NGV501252H NGV501253H NGV501254H NGV501255H NGV501257H NGV501258H NGV501259H NGV501260H NGV501263H NGV501264H NGV501271H NGV501273H NGV501274H NGV501276H NGV501277H NGV501278H NGV501279H NGV501281H NGV501282H NGV501283H NGV501284H NGV501288H NGV501292H NGV501295H NGV501296H NGV501297H NGV501299H NGV501300H NGV501301H NGV501302H NGV501303H NGV501304H NGV501306H NGV501308H NGV501309H NGV501315H NGV501316H NGV501320H NGV501322H NGV501336H NGV501338H NGV501339H NGV501410H NGV501498H NGP411641H NGP411644H NGP412195H NGV499984H NGP411637H NGV499852H NGV497975H NGP411610H NGP412268H NGP410214H NGV501163H NGP410152H NGP412287H NGV500834H NGV500770H NGP412259H NGV500151H NGP411518H NGV500661H NGP411031H NGV500742H NGP412187H NGP412285H NGV501148H NGP412775H NGV499898H NGV499915H NGP412189H NGP411090H NGV501131H NGV501289H NGP411972H NGP412188H NGV500474H NGV501319H NGV500708H NGV500442H NGP412541H NGV501143H NGV501144H NGP412881H NGP411746H NGP411717H NGP412568H NGV500711H NGV499839H NGP411618H NGP411619H NGP411620H NGV499923H NGP411099H NGP412769H NGV500731H NGP411545H NGP412539H NGV501142H NGP412662H NGP411814H NGP411816H NGP411817H NGP411819H NGP411821H NGV499962H NGV499965H NGV499968H NGV499969H NGV499970H NGP411897H NGP411899H NGP411900H NGV498008H NGV498009H NGV498028H NGV498039H NGV498053H NGP412240H NGP411497H NGP411922H NGP411923H NGP411924H NGP411926H NGP411933H NGP411934H NGP411936H NGP411791H NGP411792H NGP411796H NGP411800H NGP411803H NGP412615H NGP412623H NGV501195H NGP410211H NGV501335H NGP411639H NGP411640H NGV499955H NGP411652H NGP411654H NGV499954H NGP411552H NGP411553H NGP411554H NGP411555H NGP411556H NGP411558H NGP411559H NGP411587H NGV499894H NGV499895H NGV499896H NGV499897H NGV500085H NGP410168H NGV500328H NGP412814H NGP412261H NGV497087H NGP412297H NGV500335H NGV500336H NGV500338H NGV500339H NGV500340H NGV500252H NGV500257H NGV500259H NGV500260H NGV500261H NGV500262H NGV500265H NGV500266H NGV500267H NGV500269H NGP411544H NGV500816H NGP412574H NGP412575H NGV500104H NGP411563H NGP411676H NGP411562H NGP411564H NGP411674H NGP411678H NGP411691H NGV497983H NGV497989H NGV497993H NGV497996H NGV497999H NGV498003H NGP411585H NGP411788H NGV499924H NGV500488H NGP411550H NGP411786H NGP411789H NGP411288H NGP411705H NGV500757H NGP411050H NGV499926H NGV500673H NGV499816H NGP411276H NGV497050H NGV500023H NGV500034H NGP412716H NGV500776H NGP412445H NGV501268H NGV500667H NGV501162H NGV501248H NGP412533H NGV501173H NGP412122H NGP411163H NGP411280H NGV499930H NGV499942H NGV499944H NGV499945H NGV499949H NGV497094H NGV500662H NGP411645H NGP411646H NGP411647H NGV499931H NGV499932H NGV499935H NGV499938H NGV499939H NGV499958H NGV499959H NGP412003H NGP411608H NGP412183H NGV500789H NGP411992H NGV500090H NGV500162H NGV500165H NGV500166H NGV500167H NGV500175H NGV500178H NGV500181H NGP412675H NGV501233H NGP410150H NGP410210H NGP411839H NGP410218H NGP410222H NGV498045H NGV501294H NGP411606H NGP411609H NGP412683H NGV500182H NGP411183H NGV500206H NGV500208H NGP411129H NGP411473H NGP411474H NGP411475H NGP411476H NGP411477H NGP411478H NGP411479H NGP411480H NGP411481H NGP411483H NGV497088H NGP412324H NGV500552H NGV500775H NGV501166H NGV497969H NGP412038H NGP411755H NGV497099H NGV500428H NGP412354H NGP412357H NGV497051H NGV499912H NGV499928H NGV499933H NGV499934H NGV499967H NGV499977H NGV499982H NGV499988H NGP411098H NGP412880H NGP411584H NGV500079H NGP411244H NGV499953H NGV500249H NGV499869H NGV500606H NGP411561H NGP411586H NGP411762H NGP412115H NGV500025H NGV500036H NGV500099H NGP411692H NGP411695H NGP410207H NGP411519H NGP411633H NGV500506H NGP412303H NGV500147H NGP411566H NGP411638H NGP412889H NGP412342H NGP411300H NGP412286H NGP411093H NGV501160H NGP412486H NGP412300H NGV497978H NGP411764H NGP411793H NGP410195H NGV500761H NGP412104H NGP412127H NGP411778H NGP411138H NGV501236H NGP412110H NGP412712H NGP412103H NGP411326H NGP412094H NGV499840H NGV501167H NGV501185H NGV501170H NGP412155H NGP412191H NGP412217H NGP412329H NGP412482H NGV500497H NGP411131H NGP411139H NGP411143H NGV499870H NGV501298H NGV501285H NGV501286H NGP411754H NGP411750H NGP412346H NGP412579H NGP412063H NGV500161H NGV500529H NGV500530H NGV500538H NGV500075H NGV499890H NGP411715H NGV501231H NGP412215H NGP412213H NGP411072H NGV500601H NGV499971H NGP412761H NGP410193H NGP412869H NGV499859H NGV501266H   OUS Serial Number NGP410145H NGP410155H NGP410157H NGP410158H NGP410159H NGP410165H NGP410166H NGP410174H NGP410187H NGP410194H NGP410203H NGP410209H NGP410212H NGP410224H NGP410225H NGP410226H NGP410227H NGP410228H NGP410229H NGP410232H NGP410243H NGP411106H NGP411109H NGP411112H NGP411115H NGP411116H NGP411119H NGP411121H NGP411122H NGP411124H NGP411125H NGP411126H NGP411130H NGP411137H NGP411140H NGP411141H NGP411145H NGP411148H NGP411150H NGP411151H NGP411152H NGP411153H NGP411156H NGP411160H NGP411166H NGP411167H NGP411168H NGP411170H NGP411172H NGP411173H NGP411174H NGP411175H NGP411177H NGP411180H NGP411181H NGP411182H NGP411184H NGP411185H NGP411188H NGP411190H NGP411192H NGP411193H NGP411194H NGP411195H NGP411199H NGP411200H NGP411206H NGP411211H NGP411218H NGP411224H NGP411226H NGP411230H NGP411232H NGP411239H NGP411241H NGP411246H NGP411250H NGP411253H NGP411254H NGP411270H NGP411273H NGP411281H NGP411285H NGP411286H NGP411294H NGP411296H NGP411297H NGP411298H NGP411302H NGP411320H NGP411326H NGP411487H NGP411490H NGP411499H NGP411502H NGP411512H NGP411673H NGP411689H NGP411694H NGP411703H NGP411707H NGP411712H NGP411718H NGP411719H NGP411743H NGP411756H NGP411761H NGP411772H NGP411835H NGP411836H NGP411838H NGP411840H NGP411841H NGP411842H NGP411843H NGP411844H NGP411848H NGP411849H NGP411850H NGP411851H NGP411852H NGP411857H NGP411858H NGP411859H NGP411861H NGP411863H NGP411867H NGP411868H NGP411869H NGP411871H NGP411879H NGP411880H NGP411884H NGP411887H NGP411889H NGP411890H NGP411904H NGP411905H NGP411921H NGP411935H NGP411938H NGP411939H NGP411940H NGP411953H NGP411960H NGP411975H NGP411995H NGP411996H NGP411999H NGP412001H NGP412002H NGP412006H NGP412017H NGP412024H NGP412031H NGP412032H NGP412033H NGP412036H NGP412074H NGP412094H NGP412103H NGP412106H NGP412108H NGP412109H NGP412110H NGP412111H NGP412114H NGP412377H NGP412382H NGP412389H NGP412391H NGP412394H NGP412395H NGP412398H NGP412414H NGP412421H NGP412424H NGP412425H NGP412432H NGP412437H NGP412440H NGP412443H NGP412449H NGP412451H NGP412456H NGP412463H NGP412464H NGP412469H NGP412582H NGP412587H NGP412590H NGP412598H NGP412705H NGP412712H NGP412734H NGP412774H NGP412806H NGP412820H NGP412831H NGP412835H NGP412860H NGP412864H NGV497971H NGV497972H NGV497973H NGV497976H NGV497977H NGV497981H NGV497984H NGV497990H NGV497992H NGV497997H NGV498000H NGV498001H NGV498004H NGV498005H NGV498006H NGV498007H NGV498010H NGV498017H NGV498029H NGV498032H NGV498033H NGV498034H NGV498036H NGV498037H NGV498038H NGV498041H NGV498043H NGV498047H NGV498048H NGV498051H NGV498055H NGV498059H NGV498060H NGV499821H NGV499888H NGV499899H NGV499900H NGV499904H NGV499906H NGV499943H NGV499951H NGV499964H NGV499986H NGV499987H NGV499997H NGV500013H NGV500091H NGV500100H NGV500113H NGV500120H NGV500123H NGV500127H NGV500134H NGV500137H NGV500149H NGV500155H NGV500156H NGV500157H NGV500158H NGV500168H NGV500171H NGV500174H NGV500185H NGV500187H NGV500192H NGV500200H NGV500205H NGV500210H NGV500212H NGV500216H NGV500229H NGV500231H NGV500234H NGV500238H NGV500241H NGV500244H NGV500247H NGV500273H NGV500282H NGV500294H NGV500296H NGV500310H NGV500312H NGV500317H NGV500346H NGV500431H NGV500436H NGV500444H NGV500445H NGV500446H NGV500447H NGV500448H NGV500449H NGV500450H NGV500451H NGV500460H NGV500463H NGV500468H NGV500494H NGV500511H NGV500688H NGV500689H NGV500704H NGV500719H NGV500729H NGV500730H NGV500735H NGV500746H NGV500747H NGV500773H NGV500777H NGV500779H NGV500780H NGV500785H NGV500788H NGV500797H NGV500829H NGV500831H NGV500839H NGV500877H NGV501243H NGV501280H NGV501305H                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              
Recalling Firm/
Manufacturer
Medtronic Neuromodulation
7000 Central Ave Ne
Minneapolis MN 55432-3568
For Additional Information Contact Customer Service
888-638-7627
Manufacturer Reason
for Recall
Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function.
FDA Determined
Cause 2
Process control
Action Customers were sent a Medtronic "Urgent Medical Device Removal" letter dated April 2015. The letter described the problem and the product involved in the recall. The letter described the "Required Actions" which included to quarantine and return the product, complete and return the Customer Confirmation Form, and to share the notification with other customers. For questions, they can contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. A second letter was sent to Healthcare Professional. The "Urgent Medical Device Correction" letter dated April 2015 described the Nature of the Device Issue, Scope and Likelihood of the Issue, Recommendations, Patient Management Recommendations and Additional Information. Advise consignees to report any malfunction or adverse event related to a device to Medtronic Neuromodulation Technical Services, at 1-800-707-0933 available weekdays from 7 am - 6pm Central Time, and to FDA'ss MedWatch Program (www.fda.gov/medwatch).
Quantity in Commerce 1901 (1576 US, 325 OUS)
Distribution Worldwide Distribution - US Nationwide including DC AND PR and in the countries of : Argentina, Austria, Belgium, France, Germany, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Norway, Panama, Poland, Portugal, Russian Federation, San Marino, Saudi Arabia, South Korea, Spain, Switzerland, and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LKK and Original Applicant = MEDTRONIC Inc.
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