Events

Recall of MiniMed 640G Insulin Pump

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic MiniMed Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72352
  • Event Risk Class
    Class 2
  • Event Number
    Z-0438-2016
  • Event Date Posted
    2015-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140715
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Pump, infusion, insulin, to be used with invasive glucose sensor - Product Code OYC
  • Reason
    The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. possible cause is either lack of greasing or deficient greasing in a ball bearing assembly of the motor.
  • Action
    Medtronic sent an Urgent Medical Device Recall Notification dated September 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letters stated that the pump drive motors may experience a malfunction which would result in a pump error message alarm notifying the patient that insulin is no longer being delivered. The letters also inform the customers of what actions are to be taken. Customers with questions are instructed to contact Medtronic MiniMed's customer support team. For further questions please call (818) 576-4700.

Device

MiniMed 640G Insulin Pump
  • Model / Serial
    NG1000742H NG1001185H NG1001199H NG1001204H NG1001206H NG1002461H NG1006813H NG1007995H NG1013701H NG1015570H NG1016916H NG1017305H NG1019509H NG1019517H NG1019519H NG1019521H NG1019522H NG1019523H NG1019528H NG1019530H NG1019533H NG1019534H NG1019536H NG1019543H NG1019544H NG1019547H NG1019549H NG1019550H NG1019551H NG1019553H NG1019555H NG1019556H NG1019557H NG1019558H NG1019559H NG1019561H NG1019562H NG1019564H NG1019565H NG1019566H NG1019567H NG1019568H NG1019569H NG1019571H NG1019572H NG1019573H NG1019576H NG1019577H NG1019578H NG1019579H NG1019580H NG1019581H NG1019583H NG1019585H NG1019586H NG1019587H NG1019588H NG1019589H NG1019590H NG1019591H NG1019595H NG1019596H NG1019597H NG1019598H NG1019600H NG1019601H NG1019602H NG1019603H NG1019604H NG1019606H NG1019607H NG1019608H NG1019609H NG1019610H NG1019611H NG1019612H NG1019613H NG1019615H NG1019616H NG1019617H NG1019618H NG1019619H NG1019620H NG1019621H NG1019622H NG1019623H NG1019624H NG1019625H NG1019626H NG1019627H NG1019628H NG1019630H NG1019631H NG1019632H NG1019633H NG1019634H NG1019635H NG1019636H NG1019637H NG1019638H NG1019640H NG1019641H NG1019642H NG1019644H NG1019646H NG1019647H NG1019649H NG1019650H NG1019651H NG1019652H NG1019654H NG1019655H NG1019656H NG1019657H NG1019658H NG1019659H NG1019663H NG1019664H NG1019666H NG1019667H NG1019669H NG1019670H NG1019671H NG1019672H NG1019673H NG1019674H NG1019676H NG1019677H NG1019678H NG1019679H NG1019680H NG1019681H NG1019682H NG1019683H NG1019684H NG1019686H NG1019688H NG1019689H NG1019691H NG1019692H NG1019693H NG1019695H NG1019696H NG1019697H NG1019698H NG1019699H NG1019701H NG1019702H NG1019703H NG1019704H NG1019705H NG1019706H NG1019707H NG1019708H NG1019709H NG1019710H NG1019713H NG1019714H NG1019715H NG1019716H NG1019717H NG1019718H NG1019720H NG1019721H NG1019722H NG1019723H NG1019725H NG1019726H NG1019727H NG1019730H NG1019731H NG1019732H NG1019733H NG1019734H NG1019735H NG1019736H NG1019737H NG1019739H NG1019740H NG1019741H NG1019743H NG1019744H NG1019745H NG1019746H NG1019747H NG1019748H NG1019749H NG1019750H NG1019752H NG1019755H NG1019757H NG1019758H NG1019759H NG1019760H NG1019761H NG1019762H NG1019763H NG1019764H NG1019765H NG1019767H NG1019768H NG1019769H NG1019772H NG1019776H NG1019777H NG1019780H NG1019781H NG1019782H NG1019824H NG1019825H NG1019826H NG1019829H NG1019831H NG1019832H NG1019833H NG1019835H NG1019836H NG1019837H NG1019838H NG1019839H NG1019840H NG1019842H NG1019843H NG1019844H NG1019845H NG1019849H NG1019850H NG1019851H NG1019852H NG1019853H NG1019854H NG1019855H NG1019856H NG1019857H NG1019858H NG1019859H NG1019861H NG1019863H NG1019864H NG1019866H NG1019867H NG1019868H NG1019869H NG1019870H NG1019872H NG1019873H NG1019874H NG1019875H NG1019876H NG1019881H NG1019882H NG1019883H NG1019884H NG1019885H NG1019886H NG1019888H NG1019889H NG1019890H NG1019891H NG1019892H NG1019894H NG1019895H NG1019896H NG1019897H NG1019898H NG1019899H NG1019900H NG1019955H NG1019958H NG1019959H NG1019962H NG1019964H NG1020033H NG1020034H NG1020035H NG1020036H NG1020037H NG1020038H NG1020039H NG1020040H NG1020041H NG1020042H NG1020044H NG1020046H NG1020047H NG1020049H NG1020050H NG1020051H NG1020052H NG1020053H NG1020054H NG1020055H NG1020057H NG1020058H NG1020059H NG1020060H NG1020061H NG1020062H NG1020063H NG1020064H NG1020065H NG1020067H NG1020068H NG1020069H NG1020070H NG1020071H NG1020072H NG1020073H NG1020074H NG1020075H NG1020076H NG1020077H NG1020078H NG1020079H NG1020080H NG1020081H NG1020082H NG1020083H NG1020084H NG1020085H NG1020086H NG1020087H NG1020088H NG1020089H NG1020090H NG1020091H NG1020093H NG1020094H NG1020096H NG1020097H NG1020098H NG1020099H NG1020101H NG1020105H NG1020106H NG1020107H NG1020108H NG1020109H NG1020111H NG1020112H NG1020113H NG1020116H NG1020117H NG1020118H NG1020125H NG1020128H NG1020129H NG1020130H NG1020132H NG1020133H NG1020135H NG1020136H NG1020139H NG1020140H NG1020142H NG1020145H NG1020147H NG1020148H NG1020150H NG1020151H NG1020152H NG1020153H NG1020154H NG1020156H NG1020160H NG1020161H NG1020162H NG1020163H NG1020164H NG1020165H NG1020166H NG1020167H NG1020168H NG1020169H NG1020171H NG1020172H NG1020173H NG1020174H NG1020175H NG1020177H NG1020178H NG1020179H NG1020182H NG1020183H NG1020184H NG1020185H NG1020186H NG1020187H NG1020190H NG1020191H NG1020192H NG1020193H NG1020196H NG1020198H NG1020199H NG1020201H NG1020202H NG1020203H NG1020207H NG1020208H NG1020210H NG1020211H NG1020214H NG1020215H NG1020217H NG1020218H NG1020222H NG1020223H NG1020224H NG1020225H NG1020226H NG1020227H NG1020228H NG1020229H NG1020230H NG1020231H NG1020234H NG1020235H NG1020237H NG1020240H NG1020241H NG1020244H NG1020245H NG1020246H NG1020247H NG1020248H NG1020249H NG1020250H NG1020251H NG1020252H NG1020253H NG1020261H NG1020262H NG1020263H NG1020264H NG1020265H NG1020266H NG1020267H NG1020268H NG1020270H NG1020271H NG1020272H NG1020275H NG1020276H NG1020277H NG1020278H NG1020281H NG1020282H NG1020283H NG1020284H NG1020285H NG1020286H NG1020287H NG1020288H NG1020289H NG1020293H NG1020295H NG1020299H NG1020300H NG1020301H NG1020302H NG1020304H NG1020305H NG1020307H NG1020308H NG1020309H NG1020310H NG1020312H NG1020314H NG1020316H NG1020319H NG1020320H NG1020321H NG1020322H NG1020323H NG1020324H NG1020325H NG1020329H NG1020330H NG1020331H NG1020332H NG1020334H NG1020335H NG1020336H NG1020338H NG1020339H NG1020340H NG1020343H NG1020344H NG1020345H NG1020346H NG1020347H NG1020348H NG1020350H NG1020351H NG1020352H NG1020353H NG1020355H NG1020356H NG1020357H NG1020358H NG1020359H NG1020361H NG1020362H NG1020364H NG1020365H NG1020366H NG1020367H NG1020368H NG1020369H NG1020372H NG1020373H NG1020374H NG1020375H NG1020376H NG1020377H NG1020378H NG1020379H NG1020381H NG1020383H NG1020385H NG1020386H NG1020387H NG1020388H NG1020390H NG1020391H NG1020392H NG1020393H NG1020504H NG1020506H NG1020507H NG1020508H NG1020509H NG1020510H NG1020511H NG1020512H NG1020513H NG1020514H NG1020515H NG1020516H NG1020519H NG1020520H NG1020521H NG1020522H NG1020524H NG1020525H NG1020526H NG1020527H NG1020528H NG1020529H NG1020530H NG1020531H NG1020532H NG1020533H NG1020534H NG1020535H NG1020536H NG1020537H NG1020540H NG1020542H NG1020543H NG1020546H NG1020547H NG1020548H NG1020549H NG1020550H NG1020551H NG1020552H NG1020553H NG1020554H NG1020555H NG1020572H NG1020575H NG1020579H NG1020580H NG1020581H NG1020584H NG1020585H NG1020586H NG1020588H NG1020593H NG1020594H NG1020596H NG1020610H NG1021630H NG1021633H NG1021634H NG1021637H NG1021640H NG1021653H NG1021657H NG1021658H NG1021659H NG1021660H NG1021671H NG1021672H NG1021679H NG1021691H NG1021695H NG1021697H NG1021698H NG1021702H NG1021705H NG1021707H NG1021708H NG1021710H NG1021711H NG1021712H NG1021714H NG1021715H NG1021717H NG1021718H NG1021720H NG1021721H NG1021722H NG1021723H NG1021725H NG1021727H NG1021728H NG1021730H NG1021731H NG1021733H NG1021735H NG1021738H NG1021739H NG1021740H NG1021741H NG1021742H NG1021743H NG1021744H NG1021745H NG1021748H NG1021750H NG1021753H NG1021756H NG1021757H NG1021758H NG1021760H NG1021761H NG1021762H NG1021763H NG1021764H NG1021765H NG1021767H NG1021768H NG1021771H NG1021772H NG1021773H NG1021774H NG1021775H NG1021776H NG1021777H NG1021779H NG1021780H NG1021781H NG1021783H NG1021785H NG1021789H NG1021795H NG1021796H NG1021798H NG1021799H NG1021800H NG1021802H NG1021804H NG1021805H NG1021806H NG1021808H NG1021811H NG1021814H NG1021815H NG1021818H NG1021819H NG1021821H NG1021824H NG1021826H NG1021827H NG1021829H NG1021833H NG1021834H NG1021858H NG1021883H NG1021913H NG1021934H NG1021943H NG1021948H NG1021950H NG1021983H NG1021984H NG1021985H NG1021986H NG1021987H NG1021988H NG1021989H NG1021991H NG1021995H NG1021997H NG1021999H NG1022000H NG1022002H NG1022004H NG1022005H NG1022012H NG1022013H NG1022015H NG1022016H NG1022017H NG1022018H NG1022019H NG1022021H NG1022022H NG1022023H NG1022026H NG1022027H NG1022028H NG1022034H NG1022036H NG1022038H NG1022043H NG1022046H NG1022047H NG1022049H NG1022052H NG1022059H NG1022060H NG1022061H NG1022062H NG1022064H NG1022065H NG1022066H NG1022069H NG1022071H NG1022072H NG1022076H NG1022077H NG1022079H NG1022083H NG1022084H NG1022086H NG1022089H NG1022090H NG1022091H NG1022094H NG1022185H NG1022186H NG1022188H NG1022190H NG1022191H NG1022192H NG1022196H NG1022198H NG1022199H NG1022200H NG1022201H NG1022202H NG1022206H NG1022207H NG1022212H NG1022215H NG1022216H NG1022218H NG1022219H NG1022220H NG1022221H NG1022222H NG1022224H NG1022225H NG1022226H NG1022227H NG1022228H NG1022229H NG1022230H NG1022231H NG1022232H NG1022233H NG1022235H NG1022236H NG1022237H NG1022238H NG1022239H NG1022240H NG1022241H NG1022243H NG1022244H NG1022245H NG1022246H NG1022247H NG1022248H NG1022249H NG1022251H NG1022254H NG1022256H NG1022257H NG1022258H NG1022260H NG1022261H NG1022262H NG1022263H NG1022264H NG1022265H NG1022266H NG1022267H NG1022268H NG1022270H NG1022272H NG1022273H NG1022274H NG1022275H NG1022276H NG1022277H NG1022280H NG1022281H NG1022282H NG1022283H NG1022284H NG1022287H NG1022289H NG1022293H NG1022294H NG1022295H NG1022296H NG1022297H NG1022298H NG1022300H NG1022301H NG1022303H NG1022304H NG1022305H NG1022309H NG1022310H NG1022313H NG1022314H NG1022315H NG1022316H NG1022317H NG1022318H NG1022319H NG1022320H NG1022323H NG1022324H NG1022326H NG1022327H NG1022329H NG1022331H NG1022333H NG1022334H NG1022336H NG1022338H NG1022340H NG1022341H NG1022343H NG1022346H NG1022348H NG1022349H NG1022350H NG1022352H NG1022353H NG1022354H NG1022355H NG1022356H NG1022357H NG1022358H NG1022359H NG1022361H NG1022362H NG1022363H NG1022365H NG1022366H NG1022367H NG1022370H NG1022371H NG1022372H NG1022373H NG1022374H NG1022376H NG1022378H NG1022379H NG1022381H NG1022389H NG1022426H NG1022427H NG1022429H NG1022433H NG1022434H NG1022436H NG1022437H NG1022438H NG1022439H NG1022444H NG1022447H NG1022449H NG1022450H NG1022451H NG1022452H NG1022454H NG1022456H NG1022457H NG1022458H NG1022459H NG1022460H NG1022462H NG1022464H NG1022465H NG1022469H NG1022470H NG1022472H NG1022473H NG1022474H NG1022475H NG1022476H NG1022477H NG1022479H NG1022480H NG1022482H NG1022483H NG1022484H NG1022489H NG1022490H NG1022491H NG1022492H NG1022494H NG1022495H NG1022496H NG1022497H NG1022499H NG1022500H NG1022501H NG1022502H NG1022503H NG1022504H NG1022505H NG1022506H NG1022507H NG1022508H NG1022509H NG1022511H NG1022513H NG1022514H NG1022515H NG1022579H NG1022618H NG1022619H NG1022621H NG1022623H NG1022624H NG1022625H NG1022626H NG1022628H NG1022630H NG1022631H NG1022632H NG1022633H NG1022634H NG1022636H NG1022637H NG1022640H NG1022641H NG1022646H NG1022647H NG1022649H NG1022650H NG1022652H NG1022655H NG1022657H NG1022658H NG1022659H NG1022660H NG1022664H NG1022665H NG1022667H NG1022668H NG1022670H NG1022672H NG1022673H NG1022674H NG1022675H NG1022676H NG1022677H NG1022678H NG1022679H NG1022682H NG1022686H NG1022687H NG1022690H NG1022691H NG1022692H NG1022693H NG1022694H NG1022696H NG1022697H NG1022698H NG1022703H NG1022704H NG1022708H NG1022709H NG1022710H NG1022711H NG1022712H NG1022713H NG1022716H NG1022717H NG1022718H NG1022719H NG1022720H NG1022721H NG1022722H NG1022723H NG1022724H NG1022725H NG1022726H NG1022727H NG1022728H NG1022729H NG1022730H NG1022732H NG1022733H NG1022735H NG1022736H NG1022740H NG1022741H NG1022743H NG1022744H NG1022746H NG1022747H NG1022748H NG1022749H NG1022750H NG1022752H NG1022753H NG1022755H NG1022758H NG1022759H NG1022796H NG1022801H NG1022805H NG1022806H NG1022808H NG1022810H NG1022811H NG1022812H NG1022813H NG1022814H NG1022818H NG1022819H NG1022821H NG1022824H NG1022828H NG1022829H NG1022832H NG1022833H NG1022834H NG1022842H
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Internationally Distribution only to the countries of : Australia, Austria, Belgium, Chile, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, India, Ireland, Italy, Japan, Kenya, Luxembourg, Namibia, Netherlands, Norway, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom.
  • Product Description
    MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 || The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the pump system is indicated for continuous monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes.
  • Manufacturer
    Medtronic MiniMed Inc.

Manufacturer

Medtronic MiniMed Inc.
  • Manufacturer Address
    Medtronic MiniMed Inc., 18000 Devonshire St, Northridge CA 91325-1219
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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