Devices

Device Recall Maximo II CRT

  • Modèle / numéro de série
    Lot Serial No PZP600096S PZP600610S PZP600608S PZP600546S PZP600149S PZP600569S PZP600587S PZP600589S PZP600612S PZP600450S PZP600557S PZP600193S PZP600558S PZP600559S PZP600531S PZP600533S PZP600534S PZP600535S PZP600536S PZP600199S PZP600215S PZP600473S PZP600474S PZP600475S PZP600476S PZP600477S PZP600478S PZP600479S PZP600480S PZP600607S PZP600513S PZP600514S PZP600515S PZP600516S PZP600530S PZP600092S PZP600093S PZP600562S PZP600571S PZP600609S PZP600596S PZP600166S PZP600467S PZP600529S PZP600638S PZP600134S PZP600135S PZP600172S PZP600133S PZP600509S PZP600128S PZP600196S PZP600103S PZP600111S PZP600140S PZP600142S PZP600169S PZP600527S PZP600611S PZP600636S PZP600656S PZP600614S PZP600090S PZP600141S PZP600195S PZP600137S PZP600089S PZP600112S PZP600178S PZP600127S PZP600173S PZP600211S PZP600213S PZP600511S PZP600524S PZP600577S PZP600542S PZP600091S PZP600154S PZP600174S PZP600466S PZP600177S PZP600454S PZP600455S PZP600456S PZP600457S PZP600458S PZP600459S PZP600462S PZP600463S PZP600464S PZP600465S PZP600543S PZP600552S PZP600434S PZP600510S PZP600438S PZP600439S PZP600584S PZP600221S PZP600521S PZP600180S PZP600544S PZP600604S PZP600605S PZP600606S PZP600436S PZP600517S PZP600588S PZP600113S PZP600114S PZP600115S PZP600116S PZP600117S PZP600118S PZP600119S PZP600120S PZP600121S PZP600122S PZP600097S PZP600098S PZP600099S PZP600100S PZP600101S PZP600163S PZP600164S PZP600165S PZP600448S PZP600197S PZP600200S PZP600202S PZP600203S PZP600204S PZP600205S PZP600206S PZP600207S PZP600208S PZP600209S PZP600210S PZP600136S PZP600550S PZP600637S PZP600568S PZP600109S PZP600586S PZP600159S PZP600198S PZP600160S PZP600176S PZP600161S PZP600581S PZP600582S PZP600132S PZP600108S PZP600168S PZP600170S PZP600214S PZP600512S PZP600526S PZP600545S PZP600191S PZP600192S PZP600566S PZP600567S PZP600110S PZP600528S PZP600634S PZP600155S PZP600126S PZP600129S PZP600130S PZP600131S PZP600148S PZP600123S PZP600124S PZP600171S PZP600508S PZP600158S PZP600105S PZP600153S PZP600095S PZP600094S PZP600167S PZP600212S PZP600547S PZP600538S PZP600216S PZP600217S PZP600435S PZP600162S PZP600641S PZP600146S PZP600532S PZP600592S PZP600593S PZP600594S PZP600595S PZP600143S PZP600144S PZP600555S PZP600556S PZP600618S PZP600620S PZP600506S PZP600507S PZP600657S PZP600560S PZP600561S PZP600646S PZP600649S PZP600654S PZP600107S PZP600104S PZP600147S PZP600615S PZP600617S PZP600537S PZP600598S PZP600102S PZP600194S PZP600583S PZP600157S PZP600175S PZP600087S PZP600088S PZP600444S PZP600575S PZP600576S PZP600151S PZP600106S PZP600525S PZP600471S PZP600472S PZP600599S PZP600231S PZP600232S PZP600520S PZP600226S PZP600453S PZP600541S PZP600229S PZP600230S PZP600522S PZP600523S PZP600432S PZP600433S PZP600623S PZP600624S PZP600223S PZP600585S PZP600228S PZP600653S PZP600225S PZP600179S PZP600182S PZP600183S PZP600184S PZP600185S PZP600186S PZP600188S PZP600190S PZP600218S PZP600219S PZP600222S PZP600452S PZP600629S PZP600632S PZP600437S PZP600539S PZP600224S PZP600573S PZP600574S PZP600564S PZP600565S PZP600578S PZP600579S PZP600481S PZP600482S PZP600483S PZP600484S PZP600442S PZP600621S PZP600622S PZP600580S PZP600551S PZP600644S PZP600645S PZP600468S PZP600469S PZP600470S PZP600540S PZP600655S PZP600572S PZP600625S PZP600553S PZP600554S PZP600440S PZP600626S PZP600628S PZP600630S PZP600631S PZP600150S PZP600152S PZP600548S PZP600549S PZP600570S PZP600633S PZP600518S PZP600597S PZP600145S PZP600563S PZP600139S and PZP600643S.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    No US distribution. OUS to include: AUSTRIA, DENMARK, FINLAND, GERMANY, ITALY, SPAIN, SWEDEN, UK, GREECE, HONG KONG, INDIA, JORDAN, and SAUDI ARABIA.
  • Description du dispositif
    Maximo II CRT D284TRK, for ventricular pacing and defibrillation.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment
  • 1 Event

Fabricant

Medtronic Inc. Cardiac Rhythm Managment
  • Adresse du fabricant
    Medtronic Inc. Cardiac Rhythm Managment, 8200 Coral Sea St Ne, Mounds View MN 55112-4391
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA

Un dispositif médical avec un nom similaire

En savoir plus sur les données ici

Device Recall Maximo II CRTD
  • Modèle / numéro de série
    Model D284TRK, serial numbers: PZP200002H thru PZP200023H, PZP200025H thru PZP200084H, PZP200086H thru PZP200132H, PZP200134H thru PZP200228H, PZP200230H thru PZP200266H, PZP200268H, PZP200271H, PZP200272H, PZP200273H, PZP200275H thru PZP200361H, PZP200363H, PZP200364H, PZP200365H, PZP200366H, PZP200367H, PZP200369H thru PZP200442H, PZP200444H thru PZP200533H, PZP200535H thru PZP200602H, PZP200604H, PZP200605H, PZP200606H, PZP200607H, PZP200608H, PZP200609H, PZP200611H, PZP200613H thru PZP200770H, PZP200772H thru PZP200782H, PZP200784H, PZP200785H, PZP200787H, PZP200788H, PZP200789H, PZP200790H, PZP200791H, PZP200792H, PZP200793H, PZP200794H, PZP200795H, PZP200797H thru PZP200830H, PZP200832H thru PZP201059H, PZP201061H, PZP201062H, PZP201063H, PZP201064H, PZP201065H, PZP201066H, PZP201067H, PZP201068H, PZP201070H thru PZP201089H, PZP201091H thru PZP201209H, PZP201211H thru PZP201300H, PZP201302H thru PZP201341H, PZP201343H thru PZP201385H, PZP201387H thru PZP201422H, PZP201424H thru PZP201442H, PZP201444H, PZP201445H, PZP201446H, PZP201447H, PZP201449H thru PZP201471H, PZP201473H thru PZP201519H, PZP201521H thru PZP201633H, PZP201635H, PZP201636H, PZP201637H, PZP201639H, PZP201640H, PZP201641H, PZP201642H, PZP201643H, PZP201644H, PZP201645H, PZP201646H, PZP201647H, PZP201648H, PZP201649H, PZP201650H, PZP201651H, PZP201652H, PZP201653H, PZP201654H, PZP201655H, PZP201657H thru PZP201685H, PZP201687H, PZP201688H, PZP201690H, PZP201692H thru PZP201846H, PZP201848H thru PZP201903H, PZP201905H thru PZP202071H, PZP202073H thru PZP202136H, PZP202138H thru PZP202211H, PZP202213H thru PZP202244H, PZP202246H, PZP202247H, PZP202248H, PZP202249H, PZP202250H, PZP202251H, PZP202252H, PZP202253H, PZP202254H, PZP202255H, PZP202257H, PZP202258H, PZP202259H, PZP202260H, PZP202261H, PZP202262H, PZP202263H, PZP202265H, PZP202266H, PZP202268H, PZP202269H, PZP202270H, PZP202271H, PZP202272H, PZP202273H, PZP202274H, PZP202275H, PZP202276H, PZP202278H, PZP202279H, PZP202280H, PZP202281H, PZP202282H, PZP202283H, PZP202284H, PZP202285H, PZP202286H, PZP202287H, PZP202288H, PZP202291H, PZP202292H, PZP202293H, PZP202294H, PZP202295H, PZP202296H, PZP202297H, PZP202299H thru PZP202315H, PZP202317H thru PZP202402H, PZP202404H thru PZP202495H, PZP202497H thru PZP202635H, PZP202637H thru PZP202699H, PZP202701H thru PZP202743H, PZP202745H thru PZP202756H, PZP202758H, PZP202759H thru PZP202953H, PZP202955H, thru PZP203089H, PZP203091H thru PZP203151H, PZP203153H, PZP203154H, PZP203155H, PZP203156H, PZP203158H thru PZP203203H, PZP203205H thru PZP203257H, PZP203259H thru PZP203286H, PZP203288H, PZP203289H, PZP203290H, PZP203291H, PZP203292H, PZP203294H, PZP203297H thru PZP203329H, PZP203331H, PZP203332H, PZP203334H, PZP203335H, PZP203336H, PZP203337H, PZP203338H, PZP203339H, PZP203340H, PZP203342H, PZP203343H, PZP203344H, PZP203345H, PZP203346H, PZP203347H, PZP203348H, PZP203349H, PZP203350H, PZP203351H, PZP203352H, PZP203353H, PZP203354H, PZP203355H, PZP203356H, PZP203357H, PZP203358H, PZP203360H, thru PZP203433H, PZP203435H thru PZP203459H, PZP203461H thru PZP203507H, PZP203509H thru PZP203526H, PZP203528H thru PZP203754H, PZP203756H, PZP203757H, PZP203758H, PZP203759H, PZP203760H, PZP203761H, PZP203762H, PZP203763H, PZP203764H, PZP203765H, PZP203766H, PZP203767H, PZP203768H, PZP203770H thru PZP203847H, PZP203849H thru PZP204116H, PZP204118H thru PZP204160H, PZP204162H thru PZP204260H, PZP204262H thru PZP204276H, PZP204278H thru PZP204519H, PZP204521H thru PZP204585H, PZP204587H, PZP204588H thru PZP204618H, PZP204620H thru PZP204711H, PZP204713H thru PZP204883H, PZP204885H thru PZP204940H, PZP204942H, PZP204943H, PZP204946H, PZP204948H thru PZP205027H, PZP205029H thru PZP205111H, PZP205113H thru PZP205122H, PZP205124H, PZP205125H, PZP205126H, PZP205127H, PZP205129H thru PZP205213H, PZP205215H thru PZP205255H, PZP205257H thru PZP205328H, PZP205330H thru PZP205391H, PZP205393H thru PZP205447H, PZP205449H thru PZP205903H, PZP205905H thru PZP206021H, PZP206023H thru PZP206078H, PZP206080H, thru PZP206108H, PZP206110H, thru PZP206161H, PZP206163H thru PZP206193H, PZP206195H thru PZP206245H, PZP206249H, PZP206251H thru PZP206354H, PZP206356H thru PZP206430H, PZP206432H thru PZP206618H, PZP206620H thru PZP206663H, PZP206665H thru PZP206713H, PZP206716H PZP206859H thru PZP207074H, PZP207076H thru PZP207093H, PZP207095H thru PZP207147H, PZP207149H thru PZP207214H, PZP207216H thru PZP207255H, PZP207257H thru PZP207284H, PZP207286H thru PZP207381H, PZP207383H thru PZP207405H, PZP207407H, PZP207409H, PZP207410H, PZP207411H, PZP207412H, PZP207413H, PZP207415H thru PZP207621H, PZP207623H thru PZP207674H, PZP207676H thru PZP207823H, PZP207826H thru PZP208195H, PZP208197H, PZP208198H thru PZP208218H, PZP208220H thru PZP208362H, PZP208364H thru PZP208420H, PZP208422H, PZP208424H thru PZP208465H, PZP208467H thru PZP208878H, PZP208880H thru PZP208921H, PZP208923H thru PZP208970H, PZP208972H thru PZP209136H, PZP209138H thru PZP209219H, PZP209221H thru PZP209257H, PZP209259H thru PZP209585H, PZP209588H thru PZP209730H, PZP209732H thru PZP209750H, PZP209752H thru PZP209768H, PZP209770H thru PZP209804H, PZP209807H thru PZP209886H, PZP209888H, PZP209891H thru PZP209933H, PZP209935H thru PZP209977H, PZP209979H thru PZP210069H, PZP600001S, PZP600002S, PZP600003S, PZP600004S, PZP600005S, PZP600006S, PZP600087S thru PZP600180S, PZP600182S, PZP600183S, PZP600184S, PZP600185S, PZP600186S, PZP600187S, PZP600188S, PZP600190S, PZP600191S, PZP600192S, PZP600193S, PZP600194S, PZP600195S, PZP600196S, PZP600197S, PZP600198S, PZP600199S, PZP600200S, PZP600202S thru PZP600219S, PZP600221S thru PZP600278S, PZP600280S, PZP600281S, PZP600282S, PZP600283S, PZP600284S, PZP600285S, PZP600286S, PZP600287S, PZP600289S, PZP600291S, PZP600292S, PZP600293S, PZP600295S thru PZP600313S, PZP600318S, PZP600319S, PZP600320S, PZP600323S, PZP600324S, PZP600325S, PZP600326S, PZP600327S, PZP600328S, PZP600331S, PZP600334S, PZP600335S, PZP600336S, PZP600338S, PZP600339S, PZP600340S, PZP600341S, PZP600342S, PZP600343S, PZP600345S, PZP600346S, PZP600347S, PZP600348S, PZP600350S thru PZP600394S, PZP600396S, PZP600397S, PZP600398S, PZP600399S, PZP600401S thru PZP600421S, PZP600423S, PZP600424S, PZP600425S, PZP600426S, PZP600427S, PZP600429S, PZP600430S, PZP600431S, PZP600432S, PZP600433S, PZP600434S, PZP600435S, PZP600436S, PZP600437S, PZP600438S, PZP600439S, PZP600440S, PZP600442S, PZP600443S, PZP600444S, PZP600448S, PZP600450S, PZP600452S, PZP600453S, PZP600454S, PZP600455S, PZP600456S, PZP600457S, PZP600458S, PZP600459S, PZP600462S thru PZP600618S, PZP600620S thru PZP600676S, PZP600678S thru PZP600729S, PZP600731S thru PZP600740S, PZP600742S, PZP600743S, PZP600745S thru PZP600795S, PZP600797S, PZP600798S, PZP600799S, PZP600800S, PZP600801S, PZP600802S, PZP600803S, PZP600804S, PZP600806S, PZP600807S, PZP600808S, PZP600809S, PZP600810S, PZP600811S, PZP600813S thru PZP600884, PZP600888S thru PZP601107S, PZP601109S thru PZP601127S, PZP601129S thru PZP601149S, PZP601152S thru PZP601165S, PZP601167S thru PZP601289S, PZP601291S thru PZP601340S, PZP601342S thru PZP601363S, PZP601365S, PZP601366S, PZP601367S, PZP601368S, PZP601369S, PZP601371S, PZP601372S, PZP601373S, PZP601375S, PZP601376S, PZP601377S, PZP601378S, PZP601379S, PZP601380S, PZP601381S, PZP601383S, PZP601384S, PZP601385S, PZP601387S thru PZP601423S, PZP601425S thru PZP601648S, PZP601650S thru PZP601825S, PZP601827S thru PZP601879S, PZP601881S thru PZP602022S, PZP602024S thru PZP602139S, PZP602141S thru PZP602196S, PZP602198S thru PZP602309S, PZP602311S thru PZP602426S, PZP602428S thru PZP602631S, PZP602633S thru PZP602723S, PZP602725S thru PZP602743S, PZP602745S, PZP602746S, PZP602747S, PZP602748S, PZP602749S, PZP602751S thru PZP602971S, PZP602973S, PZP602974S, PZP602975S, PZP602976S, PZP602977S, PZP602978S, PZP602979S, PZP602981S thru PZP602998S, PZP603000S thru PZP603406S, PZP603408S thru PZP603537S, PZP603539S thru PZP603587S, PZP603589S thru PZP603654S, PZP603656S, PZP603657S, PZP603658S, PZP603659S, PZP603660S, PZP603661S, PZP603663S, PZP603664S, PZP603665S, PZP603666S, PZP603667S, PZP603668S, PZP603669S, PZP603670S, PZP603671S, PZP603672S, PZP603674S thru PZP603981S, PZP603983S thru PZP604206S, PZP604208S thru PZP604399S, PZP604401S thru PZP604486S, PZP604488S thru PZP604556S, PZP604558S thru PZP604593S, PZP604595S thru PZP604901S, PZP604903S thru PZP605233S, PZP605235S thru PZP605450S, PZP605452S thru PZP605755S, PZP605757S thru PZP605786S, PZP605788S thru PZP605871S, PZP605873S thru PZP605989S, PZP605991S thru PZP606109S, PZP606111S thru PZP606164S, PZP606166S thru PZP606244S, PZP606246S thru PZP606276S, PZP606278S thru PZP606307S, PZP606309S thru PZP606542S, PZP606544S thru PZP606673S, PZP606676S thru PZP606940S, PZP606942S thru PZP606979S, PZP606981S thru PZP607092S, PZP607094S thru PZP607115S, PZP607117S thru PZP607176S, PZP607192S, PZP607194S, PZP607200S thru PZP607208S,
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    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.
  • Description du dispositif
    Medtronic Maximo II CRT-D, model D284TRK. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (VVE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA. || The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular 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). Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device responds to bradyarrhythmias by providing bradycardia pacing therapies.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Managment