Maximo II DR

Yes

Active implantable medical devices

Press release: Software Defects Cause Malfunctioning in Medtronic's Implantable Cardiac Devices

Lot Serial No PZM600131S PZM600054S PZM600616S PZM600617S PZM600620S PZM600615S PZM600523S PZM600111S PZM600213S PZM600502S PZM600595S PZM600600S PZM600277S PZM600078S PZM600581S PZM600582S PZM600597S PZM600602S PZM600530S PZM600108S PZM600495S PZM600497S PZM600498S PZM600500S PZM600501S PZM600151S PZM600152S PZM600153S PZM600446S PZM600447S PZM600448S PZM600264S PZM600278S PZM600469S PZM600094S PZM600401S PZM600052S PZM600053S PZM600517S PZM600621S PZM600622S PZM600233S PZM600539S PZM600129S PZM600130S PZM600132S PZM600160S PZM600162S PZM600207S PZM600208S PZM600138S PZM600140S PZM600145S PZM600146S PZM600148S PZM600156S PZM600198S PZM600056S PZM600092S PZM600104S PZM600105S PZM600147S PZM600168S PZM600252S PZM600051S PZM600199S PZM600057S PZM600273S PZM600075S PZM600232S PZM600472S PZM600049S PZM600203S PZM600276S PZM600071S PZM600143S PZM600098S PZM600110S PZM600167S PZM600101S PZM600109S PZM600126S PZM600150S PZM600491S PZM600492S PZM600080S PZM600081S PZM600281S PZM600282S PZM600283S PZM600284S PZM600285S PZM600286S PZM600287S PZM600288S PZM600289S PZM600290S PZM600184S PZM600192S PZM600245S PZM600180S PZM600262S PZM600526S PZM600643S PZM600473S PZM600186S PZM600189S PZM600243S PZM600266S PZM600247S PZM600254S PZM600556S PZM600557S PZM600558S PZM600559S PZM600560S PZM600561S PZM600562S PZM600563S PZM600584S PZM600586S PZM600112S PZM600544S PZM600599S PZM600486S PZM600405S PZM600406S PZM600407S PZM600408S PZM600409S PZM600410S PZM600411S PZM600412S PZM600413S PZM600414S PZM600415S PZM600416S PZM600417S PZM600418S PZM600419S PZM600420S PZM600421S PZM600422S PZM600423S PZM600424S PZM600425S PZM600426S PZM600427S PZM600428S PZM600429S PZM600430S PZM600431S PZM600432S PZM600433S PZM600434S PZM600435S PZM600436S PZM600437S PZM600438S PZM600439S PZM600440S PZM600441S PZM600442S PZM600443S PZM600444S PZM600445S PZM600059S PZM600060S PZM600061S PZM600062S PZM600063S PZM600064S PZM600065S PZM600066S PZM600135S PZM600136S PZM600137S PZM600116S PZM600117S PZM600118S PZM600119S PZM600120S PZM600121S PZM600122S PZM600123S PZM600124S PZM600125S PZM600079S PZM600206S PZM600578S PZM600215S PZM600216S PZM600217S PZM600218S PZM600219S PZM600220S PZM600221S PZM600222S PZM600223S PZM600224S PZM600265S PZM600083S PZM600470S PZM600528S PZM600533S PZM600640S PZM600577S PZM600076S PZM600594S PZM600241S PZM600242S PZM600272S PZM600274S PZM600573S PZM600574S PZM600576S PZM600161S PZM600163S PZM600234S PZM600133S PZM600134S PZM600193S PZM600194S PZM600090S PZM600509S PZM600072S PZM600142S PZM600173S PZM600623S PZM600624S PZM600482S PZM600196S PZM600197S PZM600535S PZM600536S PZM600067S PZM600068S PZM600077S PZM600490S PZM600190S PZM600611S PZM600612S PZM600084S PZM600087S PZM600088S PZM600089S PZM600231S PZM600201S PZM600202S PZM600141S PZM600471S PZM600546S PZM600235S PZM600236S PZM600048S PZM600128S PZM600550S PZM600551S PZM600073S PZM600085S PZM600055S PZM600158S PZM600251S PZM600165S PZM600280S PZM600070S PZM600170S PZM600204S PZM600097S PZM600545S PZM600058S PZM600166S PZM600587S PZM600512S PZM600513S PZM600291S PZM600292S PZM600293S PZM600107S PZM600510S PZM600050S PZM600149S PZM600102S PZM600238S PZM600240S PZM600598S PZM600601S PZM600086S PZM600091S PZM600596S PZM600099S PZM600100S PZM600093S PZM600155S PZM600157S PZM600159S PZM600253S PZM600171S PZM600590S PZM600493S PZM600074S PZM600209S PZM600580S PZM600494S PZM600069S PZM600200S PZM600144S PZM600154S PZM600047S PZM600095S PZM600275S PZM600547S PZM600225S PZM600113S PZM600613S PZM600614S PZM600542S PZM600237S PZM600402S PZM600403S PZM600404S PZM600514S PZM600515S PZM600258S PZM600259S PZM600487S PZM600248S PZM600279S PZM600508S PZM600256S PZM600257S PZM600608S PZM600609S PZM600488S PZM600489S PZM600261S PZM600263S PZM600641S PZM600642S PZM600270S PZM600516S PZM600589S PZM600592S PZM600255S PZM600249S PZM600169S PZM600172S PZM600174S PZM600175S PZM600176S PZM600177S PZM600178S PZM600179S PZM600181S PZM600182S PZM600183S PZM600187S PZM600191S PZM600246S PZM600474S PZM600644S PZM600507S PZM600543S PZM600250S PZM600244S PZM600534S PZM600548S PZM600549S PZM600537S PZM600538S PZM600552S PZM600553S PZM600185S PZM600188S PZM600521S PZM600522S PZM600271S PZM600527S PZM600607S PZM600627S PZM600555S PZM600646S PZM600294S PZM600295S PZM600511S PZM600713S PZM600714S PZM600260S PZM600524S PZM600525S PZM600554S PZM600268S PZM600269S PZM600475S PZM600476S PZM600477S PZM600214S PZM600541S PZM600210S PZM600212S PZM600520S PZM600540S PZM600114S PZM600115S PZM600226S PZM600229S PZM600230S PZM600483S PZM600484S PZM600485S PZM600529S PZM600205S PZM600572S PZM600575S PZM600267S PZM600106S PZM600164S PZM600103S and PZM600645S.

Cardiovascular Devices

3

Yes

No US distribution. OUS to include: AUSTRIA, DENMARK, FINLAND, GERMANY, ITALY, SPAIN, SWEDEN, UK, GREECE, HONG KONG, INDIA, JORDAN, and SAUDI ARABIA.

Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation.

Model D284DRG, serial numbers: PZM200002H thru PZM200043H, PZM200045H, PZM200046H, PZM200047H, PZM200049H thru PZM200110H, PZM200112H thru PZM200161H, PZM200163H thru PZM200231H, PZM200233H, PZM200234H, PZM200235H, PZM200236H, PZM200237H, PZM200238H, PZM200239H, PZM200240H, PZM200242H thru PZM200261H, PZM200263H, PZM200264H, PZM200265H, PZM200267H thru PZM200401H, PZM200403H, PZM200405H thru PZM200426H, PZM200428H thru PZM200438H, PZM200440H thru PZM200540H, PZM200542H thru PZM200571H, PZM200573H thru PZM200585H, PZM200587H thru PZM200608H, PZM200610H, PZM200611H, PZM200612H, PZM200613H, PZM200614H, PZM200615H, PZM200616H, PZM200618H thru PZM200692H, PZM200694H thru PZM200762H, PZM200764H thru PZM200830H, PZM200832H, PZM200833H, PZM200834H, PZM200835H, PZM200836H, PZM200837H, PZM200839H, PZM200840H, PZM200841H, PZM200842H, PZM200843H, PZM200844H, PZM200845H, PZM200846H, PZM200847H, PZM200849H thru PZM201122H, PZM201124H thru PZM201290H, PZM201292H, PZM201293H, PZM201294H, PZM201295H, PZM201296H, PZM201297H, PZM201299H, PZM201300H, PZM201301H, PZM201302H, PZM201303H, PZM201304H, PZM201305H, PZM201306H, PZM201307H, PZM201308H, PZM201309H, PZM201310H, PZM201312H thru PZM201335H, PZM201337H thru PZM201390H, PZM201392H thru PZM201411H, PZM201413H thru PZM201431H, PZM201433H thru PZM201459H, PZM201461H thru PZM201567H, PZM201569H thru PZM201645H, PZM201647H thru PZM201692H, PZM201694H, PZM201696H thru PZM201709H, PZM201711H, PZM201712H, PZM201713H, PZM201714H, PZM201715H, PZM201717H thru PZM201794H, PZM201796H, PZM201797H, PZM201799H, PZM201801H, PZM201802H, PZM201803H, PZM201804H, PZM201805H, PZM201806H, PZM201808H thru PZM201860H, PZM201862H thru PZM201995H, PZM201998H, PZM202001H, PZM202002H, PZM202003H, PZM202004H, PZM202005H, PZM202008H, PZM202010H, PZM202011H, PZM202013H, PZM202014H, PZM202016H thru PZM202041H, PZM202044H, PZM202045H, PZM202046H, PZM202047H, PZM202049H thru PZM202066H, PZM202068H, PZM202069H, PZM202070H, PZM202071H, PZM202072H, PZM202074H, PZM202076H thru PZM202090H, PZM202092H, PZM202093H thru PZM202158H, PZM202160H, PZM202161H, PZM202162H, PZM202163H, PZM202164H, PZM202165H, PZM202166H, PZM202167H, PZM202168H, PZM202169H, PZM202171H, PZM202172H thru PZM202242H, PZM202244H thru PZM202299H, PZM202301H, PZM202302H, PZM202303H, PZM202304H, PZM202305H, PZM202306H, PZM202307H, PZM202309H thru PZM202370H, PZM202372H thru PZM202397H, PZM202399H thru PZM202423H, PZM202425H, PZM202426H, PZM202427H, PZM202428H, PZM202430H, PZM202431H, PZM202432H, PZM202433H, PZM202434H, PZM202435H, PZM202437H thru PZM202565H, PZM202567H thru PZM202647H, PZM202649H thru PZM202676H, PZM202678H thru PZM202700H, PZM202702H thru PZM202745H, PZM202747H, PZM202748H, PZM202750H, PZM202751H, PZM202752H, PZM202754H, PZM202755H, PZM202756H, PZM202757H, PZM202758H, PZM202759H, PZM202761H thru PZM202774H, PZM202776H thru PZM203008H, PZM203010H thru PZM203094H, PZM203096H, PZM203097H thru PZM203321H, PZM203323H thru PZM203374H, PZM203376H thru PZM203422H, PZM203424H thru PZM203518H, PZM203520H thru PZM203636H, PZM203638H thru PZM203818H, PZM203820H thru PZM203867H, PZM203869H thru PZM203902H, PZM203904H thru PZM204013H, PZM204015H thru PZM204095H, PZM204097H thru PZM204221H, PZM204223H thru PZM204272H, PZM204274H thru PZM204390H, PZM204391H, PZM204392H, PZM204394H, PZM204395H, PZM204397H thru PZM204410H, PZM204412H, PZM204413H, PZM204414H, PZM204415H, PZM204416H, PZM204417H, PZM204418H, PZM204419H, PZM204420H, PZM204421H, PZM204422H, PZM204424H thru PZM204492H, PZM204494H thru PZM204618H, PZM204620H thru PZM204820H, PZM204822H thru PZM204897H, PZM204899H thru PZM204913H, PZM204915H thru PZM204931H, PZM204933H thru PZM204999H, PZM205001H thru PZM205021H, PZM205023H, PZM205025H, PZM205026H thru PZM205045H, PZM205047H, PZM205048H, PZM205049H, PZM205050H, PZM205052H, PZM205053H, PZM205054H, PZM205055H, PZM205056H, PZM205058H thru PZM205095H, PZM205097H thru PZM205113H, PZM205115H thru PZM205174H, PZM205176H thru PZM205199H, PZM205201H thru PZM205247H, PZM205249H thru PZM205468H, PZM205470H, PZM205471H, PZM205472H, PZM205473H, PZM205474H, PZM205475H, PZM205476H, PZM205477H, PZM205478H, PZM205480H thru PZM205623H, PZM205625H thru PZM205638H, PZM205640H thru PZM205919H, PZM205921H, PZM205922H, PZM205923H, PZM205924H, PZM205926H thru PZM206030H, PZM206032H, PZM206033H thru PZM206077H, PZM206079H thru PZM206090H, PZM206092H thru PZM206105H, PZM206107H thru PZM206151H, PZM206153H thru PZM206210H, PZM206212H thru PZM206539H, PZM206541H thru PZM206799H, PZM206801H thru PZM206848H, PZM206850H thru PZM206907H, PZM206909Hthru PZM206918H, PZM206920H thru PZM206961H, PZM206963H thru PZM207106H, PZM207108H thru PZM207232H, PZM207234H thru PZM207276H, PZM207278H thru PZM207339H, PZM207341H thu PZM207428H, PZM207430H thru PZM207441H, PZM207443H thru PZM207564H, PZM207566H thru PZM207676H, PZM207678H thru PZM207693H, PZM207695H thru PZM207704H, PZM207706H thru PZM207805H, PZM207807H thru PZM207986H, PZM207988H thru PZM208082H, PZM208084H thru PZM208104H, PZM208106H thru PZM208143H PZM208145 thru PZM208151H, PZM208153H thru PZM208164H, PZM208166H, thru PZM208175H, PZM208177H thru PZM208189H, PZM208191H thru PZM208275H, PZM208277H thru PZM208371H, PZM208373H thru PZM208450H, PZM208452H thru PZM208563H, PZM208565H thru PZM208633H, PZM208635H thru PZM208780H, PZM208782H thru PZM209153H, PZM209155H thru PZM209250H, PZM209252H thru PZM209264H, PZM209266H thru PZM209282H, PZM209284H, PZM209285H, PZM209286H, PZM209287H, PZM209289H thru PZM209348H, PZM209350H thru PZM209382H, PZM209384H thru PZM209427H, PZM209429H thru PZM209496H, PZM209498H thru PZM209512H, PZM209514H, PZM209517H, thru PZM209568H, PZM209570H thru PZM209658H, PZM209660H, PZM209661H, PZM209662H, PZM209663H, PZM209664H, PZM209666H thru PZM209819H, PZM209821H thru PZM209878H, PZM209880H thru PZM209908H, PZM209910H thru PZM209935H, PZM209937H, PZM209940H thru PZM209962H, PZM209964H thru PZM210010H, PZM210012H thru PZM210037H, PZM210039H thru PZM210404H, PZM210406H thru PZM210462H, PZM210464H thru PZM210505H, PZM210507H thru PZM210569H, PZM210571H thru PZM210606H, PZM210608H thru PZM210779H, PZM210781H thru PZM210837H, PZM210839H, PZM210840H, PZM210841H, PZM210843H, PZM210844H, PZM210845H, PZM210846H, PZM210847H, PZM210848H, PZM210849H, PZM210850H, PZM210852H thru PZM210903H, PZM210905H thru PZM210914H, PZM210916H thru PZM210956H, PZM210958H thru PZM211011H, PZM211013H thru PZM211038H, PZM211040H thru PZM211129H, PZM211131H, PZM211133H thru PZM211165H, PZM211167H thru PZM211254H, PZM211256H thru PZM211348H, PZM211350H thru PZM211414H, PZM211416H thru PZM211427H, PZM211429H thru PZM211521H, PZM211523H thru PZM211542H, PZM211544H thru PZM211710H, PZM211712H thru PZM211863H, PZM211865H thru PZM211953H, PZM211955H thru PZM212023H, PZM212025H thru PZM212157H, PZM212159H thru PZM212210H, PZM212212H thru PZM212278H, PZM212280H thru PZM212298H, PZM212300H, PZM212301H, PZM212302H, PZM212303H, PZM212304H, PZM212305H, PZM212307H thru PZM212324H, PZM212326H thru PZM212455H, PZM212456H, PZM212457H thru PZM212502H, PZM212504H thru PZM212541H, PZM212543H, PZM212545H, PZM212547H thru PZM212561H, PZM212564H, PZM212565H, PZM212566H, PZM212567H, PZM212568H, PZM212569H, PZM212570H, PZM212571H, PZM212572H, PZM212573H, PZM212574H, PZM212575H, PZM212576H, PZM212578H thru PZM212604H, PZM212606H thru PZM212624H, PZM212626H thru PZM212640H, PZM212642H thru PZM212703H, PZM212704H, PZM212705H, PZM212706H, PZM212707H, PZM212709H thru PZM212737H, PZM212739H, PZM212741H thru PZM212785H, PZM212787H, PZM212788H thru PZM212840H, PZM212843H, PZM212844H, PZM212845H, PZM212847H, PZM212848H, PZM212849H, PZM212850H, PZM212851H, PZM212852H, PZM212853H thru PZM212947H, PZM212949H thru PZM213085H, PZM213088H, PZM213091H thru PZM213106H, PZM213108H thru PZM213201H, PZM600001S thru PZM600047S, PZM600048S thru PZM600095S, PZM600097S thru PZM600126S, PZM600128S thru PZM600138S, PZM600140S thru PZM600194S, PZM600196S thru PZM600238S, PZM600240S thru PZM600295S, PZM600297S, PZM600298S thru PZM600321S, PZM600324S, PZM600328S, PZM600333S, PZM600336S, PZM600340S, PZM600343S, PZM600345S, PZM600348S, PZM600350S, PZM600352S, PZM600354S, PZM600355S, PZM600357S, PZM600358S, PZM600359S, PZM600364S, PZM600365S, PZM600368S, PZM600370S, PZM600373S, PZM600376S, PZM600385S, PZM600388S, PZM600390S, PZM600391S, PZM600392S, PZM600396S, PZM600397S, PZM600401S thru PZM600495S, PZM600497S, PZM600498S, PZM600500S thru PZM600563S, PZM600565S thru PZM600582S, PZM600584S thru PZM600604S, PZM600606S thru PZM600676S, PZM600678S, PZM600679S, PZM600680S, PZM600682S, PZM600683S thru PZM600728S, PZM600730S thru PZM600805S, PZM600807S, PZM600808S, PZM600809S, PZM600810S, PZM600811S, PZM600812S, PZM600813S, PZM600814S, PZM600816S thru PZM600837S, PZM600839S thru PZM600882S, PZM600884S thru PZM600907S, PZM600909S thru PZM601026S, PZM601028S thru PZM601040S, PZM601042S thru PZM601088S, PZM601090S thru PZM601248S, PZM601250S thru PZM601466S, PZM601468S thru PZM601523S, PZM601525S thru PZM601545S, PZM601547S thru PZM601592S, PZM601594S thru PZM601786S, PZM601788S, PZM601789S, PZM601790S, PZM601792S, PZM601793S, PZM601794S thru PZM601936S, PZM601938S thru PZM602099S, PZM602101S thru PZM602142S, PZM602144S, PZM602167S thru PZM602355S, PZM602357S thru PZM602445S, PZM602447S thru PZM603113S, PZM603115S thru PZM603339S, PZM603341S thru PZM603460S, PZM603462S thru PZM603525S, PZM603527S thru PZM603730S, PZM603732S thru PZM603845S, PZM603847S thru PZM603930S, PZM603932S, PZM603933S, PZM603934S, PZM603935S, PZM603937S thru PZM604046S, PZM604048S, PZM604049S thru PZM604104S, PZM604106S thru PZM604185S, PZM604187S thru PZM604197S, PZM604199S thru PZM604337S, PZM604339S thru PZM604399S, PZM604401S, PZM604402S, PZM604403S, PZM604404S, PZM604405S, PZM604406S, PZM604407S, PZM604408S, PZM604409S, PZM604410S, PZM604411S, PZM604413S thru PZM604496S, PZM604498S thru PZM604668S, PZM604670S thru PZM604737S, PZM604739S thru PZM605087S, PZM605089S thru PZM605110S, PZM605112S thru PZM605528S, PZM605530S thru PZM605622S, PZM605624S thru PZM605636S, PZM605638S thru PZM605678S, PZM605680S thru PZM605850S, PZM605852S thru PZM606000S, PZM606002S thru PZM606312S, PZM606315S thru PZM606328S, PZM606330S thru PZM606370S, PZM606372S thru PZM606662S, PZM606664S thru PZM606694S, PZM606696S thru PZM606709S, PZM606711S thru PZM607263S, PZM607265S thru PZM607284S, PZM607286S thru PZM607293S, PZM607295S thru PZM607320S, PZM607322S thru PZM607361S, PZM607363S thru PZM607430S, PZM607432S thru PZM607501S, PZM607503S thru PZM607544S, PZM607546S thru PZM607569S, PZM607571S, PZM607572S, PZM607573S, PZM607575S, PZM607577S, PZM607636S.

Cardiovascular Devices

3

Yes

Worldwide Distribution - USA, Puerto Rico, Virgin Islands, and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, and Viet Nam.

Medtronic Maximo II DR, model D284DRG. Digital dual chamber implantable cardioverter defibrillator (VVE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA. || The Dual chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, and ventricular tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF). The device responds to bradyarrhythmias by providing bradycardia pacing therapies.