Class 2 Device Recall MiniMed 620G

• Date Initiated by Firm: May 08, 2017
• Create Date: July 09, 2019
• Recall Status: Terminated on January 20, 2021
• Recall Number: Z-2602-2017
• Recall Event ID: 77188
• PMA Number: P150001
• Product Classification: Artificial pancreas device system, threshold suspend - Product Code OZO
• Product: MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
• Code Information: Serial Number (MMT-1510) NG1010153U NG1010155U NG1010156U NG1010157U NG1010158U NG1010159U NG1010160U NG1010163U NG1010165U NG1010171U NG1010172U NG1010173U NG1010174U NG1010175U NG1010177U NG1010178U NG1010179U NG1010180U NG1010181U NG1010182U NG1010184U NG1010187U NG1010188U NG1010189U NG1010194U NG1010195U NG1010198U NG1010199U NG1010200U NG1010203U NG1010206U NG1010207U NG1010208U NG1010222U NG1010233U NG1010151U NG1010210U NG1010224U NG1010235U NG1010166U NG1010167U NG1010170U NG1010191U NG1010193U NG1010196U NG1010201U NG1010204U NG1010205U NG1010211U NG1010213U NG1010214U NG1010216U NG1010217U NG1010220U NG1010223U NG1010229U NG1010230U NG1010234U NG1010237U NG1010238U NG1010239U NG1010241U NG1010242U NG1010247U NG1010248U NG1010250U NG1010252U NG1010254U NG1010148U NG1010149U NG1010150U NG1010154U NG1010185U NG1010190U NG1010202U NG1010215U NG1010236U NG1010243U NG1010245U NG1010246U NG1010249U NG1010251U NG1010255U NG1010152U NG1010169U NG1010212U NG1010209U NG1010225U NG1010226U NG1010227U NG1010228U Serial No. for MMT-1550 NG1009635U NG1009754U NG1009767U NG1009748U NG1009702U NG1009742U NG1009745U NG1009708U NG1009743U NG1009765U NG1009747U NG1009768U NG1009763U NG1009752U NG1009762U NG1009764U NG1009744U NG1009665U NG1009727U NG1009719U NG1009739U NG1009700U NG1009707U NG1009735U NG1009728U NG1009740U NG1009741U NG1009667U NG1009687U NG1009732U NG1009712U NG1009722U NG1009675U NG1009678U NG1009718U NG1009679U NG1009713U NG1009736U NG1009677U NG1009688U NG1009674U NG1009729U NG1009690U NG1009698U NG1009691U NG1009714U NG1009703U NG1009676U NG1009750U NG1009710U NG1009701U NG1009715U NG1009898U NG1009897U NG1009902U NG1009891U NG1009896U NG1009892U NG1009916U NG1009917U NG1009914U NG1009887U NG1009893U NG1009911U NG1009904U NG1009905U NG1009890U Serial Number (MMT-1710) NG1035907H NG1035915H NG1035920H NG1035924H NG1035930H NG1035935H NG1035916H NG1035926H NG1035933H NG1035919H NG1035922H NG1003902H NG1004318H NG1003968H NG1004002H NG1004028H NG1009037H NG1034579H NG1034898H NG1034968H NG1038619H NG1038631H NG1038635H NG1038637H NG1038643H NG1003950H NG1034894H NG1034951H NG1038617H NG1004402H NG1004482H NG1009089H NG1038632H NG1038639H NG1038647H NG1004127H Serial No. for MMT-1750 Serial Number NG1003894H NG1003908H NG1003975H NG1003944H NG1003961H NG1003938H NG1003927H NG1003909H NG1003980H NG1003973H NG1003904H NG1003941H NG1003915H NG1003953H NG1003982H NG1003949H NG1003981H NG1003988H NG1003936H NG1003903H NG1003935H NG1003979H NG1003972H NG1003916H NG1003994H NG1003987H NG1003993H NG1003978H NG1003983H NG1003976H NG1004012H NG1003990H NG1003996H NG1004001H NG1004016H NG1004027H NG1004030H NG1004004H NG1004014H NG1004074H NG1004051H NG1004087H NG1004055H NG1004094H NG1004091H NG1004116H NG1004079H NG1004128H NG1004150H NG1004131H NG1004098H NG1004166H NG1004171H NG1004202H NG1004178H NG1004155H NG1004158H NG1004143H NG1004194H NG1004168H NG1004223H NG1004338H NG1004357H NG1004351H NG1004307H NG1004240H NG1004262H NG1004320H NG1004411H NG1004261H NG1004372H NG1004277H NG1004285H NG1004293H NG1004328H NG1004324H NG1003970H NG1003963H NG1004008H NG1003974H NG1003992H NG1003989H NG1004003H NG1004017H NG1003998H NG1004031H NG1004026H NG1004024H NG1004022H NG1004025H NG1004077H NG1004041H NG1004040H NG1004049H NG1004065H NG1004042H NG1004045H NG1004046H NG1004044H NG1004034H NG1004053H NG1004072H NG1004061H NG1004037H NG1004056H NG1004071H NG1004060H NG1004083H NG1004069H NG1004092H NG1004089H NG1004097H NG1004081H NG1004075H NG1004157H NG1004198H NG1004199H NG1004228H NG1004226H NG1004209H NG1004197H NG1004184H NG1004214H NG1004215H NG1004192H NG1004230H NG1004260H NG1004257H NG1004266H NG1004286H NG1004352H NG1004294H NG1004303H NG1004365H NG1004409H NG1004353H NG1004339H NG1004344H NG1004387H NG1004358H NG1004334H NG1004377H NG1004408H NG1004382H NG1004300H NG1004401H NG1004369H NG1004415H NG1004407H NG1004412H NG1004423H NG1004441H NG1004333H NG1004395H NG1004464H NG1004059H 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NG1008163H NG1008142H NG1008151H NG1008184H NG1008160H NG1008205H NG1008122H NG1008139H NG1008134H NG1008180H NG1008223H NG1008226H NG1008204H NG1008198H NG1008215H NG1008188H NG1008164H NG1008119H NG1008200H NG1008185H NG1008201H NG1008170H NG1008194H NG1008128H NG1008221H NG1008146H NG1008224H NG1008214H NG1008192H NG1008158H NG1008186H NG1008195H NG1008190H NG1008141H NG1008219H NG1009067H NG1009052H NG1009087H NG1009025H NG1009099H NG1009059H NG1009026H NG1009083H NG1009079H NG1009024H NG1009036H NG1009061H NG1009096H NG1009034H NG1009077H NG1009032H NG1009086H NG1009044H NG1009031H NG1009082H NG1009058H NG1009051H NG1009040H NG1009062H NG1009070H NG1009054H NG1009028H NG1009038H NG1009106H NG1009091H NG1009048H NG1009068H NG1008202H NG1009149H NG1009039H NG1009055H NG1009130H NG1009150H NG1009101H NG1009134H NG1009109H NG1009053H NG1009128H NG1009050H NG1009147H NG1009115H NG1009097H NG1009113H NG1009094H NG1009112H NG1009165H NG1009117H NG1009160H NG1009148H NG1009158H NG1009137H NG1009104H NG1009120H NG1009060H NG1009144H NG1009157H NG1009116H NG1009152H NG1009176H NG1009153H NG1009164H NG1009174H NG1009163H NG1009173H NG1009179H NG1009175H NG1009154H NG1009057H NG1009124H NG1009172H NG1009142H NG1004314H NG1008150H NG1008157H NG1008137H NG1009033H NG1009078H NG1009140H NG1009118H NG1004438H NG1009047H NG1010764H NG1010811H NG1010840H NG1010724H NG1010841H NG1010813H NG1010751H NG1010801H NG1010754H NG1010788H NG1010704H NG1010749H NG1010757H NG1010777H NG1010746H NG1010809H NG1010802H NG1010739H NG1010712H NG1010762H NG1010787H NG1010786H NG1010759H NG1010775H NG1010742H NG1010715H NG1010726H NG1010731H NG1010755H NG1010734H NG1010720H NG1010747H NG1010700H NG1010725H NG1010752H NG1010740H NG1010723H NG1010706H NG1010772H NG1010768H NG1010810H NG1010807H NG1010765H NG1010750H NG1010716H NG1010790H NG1010758H NG1010710H NG1010783H NG1010832H NG1010821H NG1010817H NG1010797H NG1010825H NG1010737H NG1010792H NG1010776H NG1010753H NG1010819H NG1010824H NG1010722H NG1010806H NG1010711H NG1010833H NG1010835H NG1010837H NG1010826H NG1003956H NG1004310H NG1008108H NG1008118H NG1008183H NG1008187H NG1008199H NG1010713H NG1010708H NG1010842H NG1010735H NG1010791H NG1010812H NG1010828H NG1010830H NG1004433H NG1004102H NG1008175H NG1008167H NG1012324H NG1012354H NG1012335H NG1012351H NG1012350H NG1012348H NG1012327H NG1012339H NG1012316H NG1012596H NG1012330H NG1012360H NG1012364H NG1012331H NG1012616H NG1012358H NG1012337H NG1012345H NG1012602H NG1012630H NG1012611H NG1012336H NG1012553H NG1012362H NG1012566H NG1012565H NG1012594H NG1012625H NG1012606H NG1012591H NG1012656H NG1012344H NG1012653H NG1012573H NG1012599H NG1012610H NG1012647H NG1012645H NG1012585H NG1012743H NG1012322H NG1012735H NG1012664H NG1012333H NG1012632H NG1012720H NG1012736H NG1012730H NG1012601H NG1012627H NG1012589H NG1012349H NG1012734H NG1012353H NG1012729H NG1012740H NG1012359H NG1012667H NG1012564H NG1012577H NG1012631H NG1012587H NG1012593H NG1012739H NG1012612H NG1012605H NG1012600H NG1012583H NG1012620H NG1012649H NG1012733H NG1012586H NG1012725H NG1012609H NG1012567H NG1012727H NG1012746H NG1012663H NG1012744H NG1012598H NG1012724H NG1012580H NG1012658H NG1012595H NG1012661H NG1012575H NG1012666H NG1004455H NG1008216H NG1009072H NG1012659H NG1012347H NG1009131H NG1013432H NG1013441H NG1013435H NG1013414H NG1013431H NG1013440H NG1013423H NG1013436H NG1013415H NG1013424H NG1013426H NG1013422H NG1013433H NG1013409H NG1013449H NG1013429H NG1013427H NG1013413H NG1013446H NG1013438H NG1013399H NG1013405H NG1013406H NG1013950H NG1013448H NG1013994H NG1013928H NG1013973H NG1013948H NG1013926H NG1013949H NG1013933H NG1013941H NG1013410H NG1013400H NG1013914H NG1014008H NG1013967H NG1013420H NG1013943H NG1013912H NG1013991H NG1013940H NG1013909H NG1013996H NG1013951H NG1013923H NG1014021H NG1013907H NG1013899H NG1013931H NG1013999H NG1013993H NG1013977H NG1013925H NG1014022H NG1013995H NG1014009H NG1013980H NG1013903H NG1013987H NG1014017H NG1013919H NG1014000H NG1013972H NG1013939H NG1013900H NG1013897H NG1013929H NG1013934H NG1013964H NG1013895H NG1013935H NG1013984H NG1014012H NG1013911H NG1013989H NG1013997H NG1013971H NG1014011H NG1014016H NG1013901H NG1013970H NG1014039H NG1014037H NG1013981H NG1013960H NG1013962H NG1014042H NG1014045H NG1013959H NG1014002H NG1014025H NG1013982H NG1013966H NG1013961H NG1013944H NG1014010H NG1014015H NG1014035H NG1013419H NG1013916H NG1013917H NG1014032H NG1014058H NG1014029H NG1014044H NG1014056H NG1014038H NG1014051H NG1014014H NG1014024H NG1014061H NG1014036H NG1014028H NG1014544H NG1014366H NG1014373H NG1014359H NG1014362H NG1014616H NG1014376H NG1014582H NG1014540H NG1014576H NG1014608H NG1014350H NG1014554H NG1014367H NG1014364H NG1014361H NG1014365H NG1014033H NG1013979H NG1014031H NG1014048H NG1014030H NG1014062H NG1014049H NG1014050H NG1014047H NG1014363H NG1014604H NG1014627H NG1014536H NG1014602H NG1014535H NG1014556H NG1014381H NG1014632H NG1014374H NG1014555H NG1014539H NG1014559H NG1014541H NG1014617H NG1014561H NG1014625H NG1014595H NG1014354H NG1014360H NG1014542H NG1014377H NG1014560H NG1014613H NG1014591H NG1014545H NG1014351H NG1014023H NG1014547H NG1014619H NG1014549H NG1014610H NG1014600H NG1014372H NG1014621H NG1014358H NG1014534H NG1014573H NG1014562H NG1014574H NG1014041H NG1014579H NG1013439H NG1009075H NG1012571H NG1012568H NG1012343H NG1012662H NG1013421H NG1014375H NG1014370H NG1014568H NG1014596H NG1014618H NG1014609H NG1014577H NG1014637H NG1014633H NG1014643H NG1014607H NG1014593H NG1014383H NG1014571H NG1014566H NG1014626H NG1014615H NG1014601H NG1014585H NG1014550H NG1014558H NG1014586H NG1014589H NG1014563H NG1014620H NG1014543H NG1014644H NG1014603H NG1014634H NG1014583H NG1014630H NG1014623H NG1014647H NG1014646H NG1014635H NG1014641H NG1014551H NG1014572H NG1014552H NG1014605H NG1014642H NG1014040H NG1017549H NG1017537H NG1017560H NG1017600H NG1017584H NG1017548H NG1017540H NG1017561H NG1017558H NG1017581H NG1017570H NG1017539H NG1017595H NG1017536H NG1017556H NG1017571H NG1017551H NG1017606H NG1017583H NG1017563H NG1017557H NG1017587H NG1017598H NG1017589H NG1017592H NG1017559H NG1017569H NG1017605H NG1017545H NG1017574H NG1017555H NG1017552H NG1017544H NG1018911H NG1018988H NG1018985H NG1018944H NG1018989H NG1018910H NG1018946H NG1018943H NG1018961H NG1018882H NG1018980H NG1018932H NG1018975H NG1018949H NG1018994H NG1018991H NG1018927H NG1018968H NG1018966H NG1018964H NG1018887H NG1018933H NG1018921H NG1018974H NG1018954H NG1018999H NG1018965H NG1018875H NG1018923H NG1018996H NG1019033H NG1018997H NG1019036H NG1019059H NG1019013H NG1019044H NG1019071H NG1018928H NG1008222H NG1019038H NG1019048H NG1018913H NG1019019H NG1019043H NG1019074H NG1019053H NG1019008H NG1019058H NG1019026H NG1019073H NG1018900H NG1019113H NG1018869H NG1019011H NG1019078H NG1019041H NG1019057H NG1018876H NG1019005H NG1019051H NG1018920H NG1019063H NG1019047H NG1019070H NG1019037H NG1018998H NG1019102H NG1018877H NG1018969H NG1019061H NG1018978H NG1018939H NG1019027H NG1019040H NG1019075H NG1019092H NG1019045H NG1019118H NG1018889H NG1019077H NG1019001H NG1019069H NG1018937H NG1018888H NG1018873H NG1018892H NG1018896H NG1019072H NG1019116H NG1019007H NG1019076H NG1019100H NG1019111H NG1018904H NG1019106H NG1019110H NG1019091H NG1019068H NG1019114H NG1017538H NG1018935H NG1018972H NG1018957H NG1019009H NG1019060H NG1018916H NG1019117H NG1019024H NG1019083H NG1018919H NG1018884H NG1019002H NG1018914H NG1019086H NG1019099H NG1019080H NG1019084H NG1019089H NG1018912H NG1018893H NG1018890H NG1019090H NG1018878H NG1019081H NG1018924H NG1018905H NG1018879H NG1018906H NG1018897H NG1019103H NG1019054H NG1018898H NG1019088H NG1018907H NG1004173H NG1019025H NG1020686H NG1020649H NG1020685H NG1019067H NG1018925H NG1018915H NG1004190H NG1019227H NG1019226H NG1019221H NG1019222H NG1004205H NG1019032H NG1020642H NG1020699H NG1020703H NG1020726H NG1020653H NG1020671H NG1020702H NG1020636H NG1020725H NG1020698H NG1020705H NG1020635H NG1020669H NG1020723H 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• Recalling Firm/ Manufacturer: Medtronic Inc.; 18000 Devonshire St; Northridge CA 91325-1219
• For Additional Information Contact: James Dabbs; 818-576-4700
• Manufacturer Reason for Recall: Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.
• FDA Determined Cause: Device Design
• Action: On May 19, 2017, an Urgent Field Safety Notification letter will be sent to customers to inform them that Medtronic MiniMed is recalling MiniMed 600 series insulin pumps because they may be temporarily stuck, and the keypad becomes unresponsive. Customers are instructed how the key becomes temporarily unresponsive, how to notice if this happens, and what to do if this happens to their pumps. Customers with questions or concerns are instructed to find an FAQ and a copy of the letter at http://www.medtronicdiabetes.com/notice6. Customers can also reach the Medtronic 24-Hour HelpLine at1-888-204-7616.
• Quantity in Commerce: 6,573 pumps
• Distribution: US and OUS Angola Aruba Australia/NZ Austria Bahamas Bahrain Bangladesh Belgium Bolivia Botswana Bulgaria Cayman Islands Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Dominican Republic El Salvador Estonia Faroe Islands Finland France Germany Greece Guadeloupe Guatemala Hong Kong Hungary Iceland India Iraq Ireland Israel Italy Japan Jordan Kazakhstan Kenya Korea Kuwait Latvia Lebanon Liechtenstein Lithuania Luxembourg Macedonia Malaysia Martinique Mauritius Morocco Namibia Nepal Netherlands New Caledonia Norway Oman Panama Paraguay Philippines Poland Portugal Qatar Reunion Romania San Marino Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Tanzania Thailand Trinidad and Tobago Turkey United Arab Emirates 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 = OZO and Original Applicant = MEDTRONIC MINIMED