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U.S. Department of Health and Human Services

Class 2 Device Recall MiniMed 640G Insulin Pump

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  Class 2 Device Recall MiniMed 640G Insulin Pump see related information
Date Initiated by Firm September 25, 2015
Date Posted December 17, 2015
Recall Status1 Terminated 3 on February 05, 2016
Recall Number Z-0438-2016
Recall Event ID 72352
Product Classification Pump, infusion, insulin, to be used with invasive glucose sensor - Product Code OYC
Product 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.
Code Information 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 NG1020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Recalling Firm/
Medtronic MiniMed Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Nonconforming Material/Component
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.
Quantity in Commerce 1052 units
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.
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.