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U.S. Department of Health and Human Services

Class 2 Device Recall MiniMed 620G Insulin Pump

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  Class 2 Device Recall MiniMed 620G Insulin Pump see related information
Date Initiated by Firm May 23, 2022
Create Date July 08, 2022
Recall Status1 Open3, Classified
Recall Number Z-1352-2022
Recall Event ID 90370
Product Classification Pump, infusion, insulin, to be used with invasive glucose sensor - Product Code OYC
Product MiniMed 620G Insulin Pump (O.U.S. version)
Code Information Product Number/CFN (O.U.S. version) MiniMed 620G (MMT-1510, MMT-1710, MMT-1750) UDI Code: Pending Serial Numbers: NG1003917H NG1004461H NG1010799H NG1012557H NG1020680H NG1026110H NG1028941H NG1028949H NG1028952H NG1028973H NG1034230H NG1034247H NG1034304H NG1034314H NG1034335H NG1034338H NG1034345H NG1034358H NG1034359H NG1034364H NG1034583H NG1034584H NG1034593H NG1034595H NG1034609H NG1035490H NG1035495H NG1035505H NG1035517H NG1035520H NG1035525H NG1035526H NG1035546H NG1035552H NG1035566H NG1035572H NG1035575H NG1035581H NG1035586H NG1035593H NG1035595H NG1035915H NG1035930H NG1035933H NG1035935H NG1036645H NG1036646H NG1036671H NG1036678H NG1036688H NG1036704H NG1036713H NG1036715H NG1036725H NG1036726H NG1036731H NG1036757H NG1036785H NG1036801H NG1036809H NG1036811H NG1036813H NG1036854H NG1039152H NG1040219H NG1040230H NG1040231H NG1040237H NG1040257H NG1040262H NG1040271H NG1040290H NG1040298H NG1040305H NG1040318H NG1040344H NG1040353H NG1040380H NG1040381H NG1040383H NG1040480H NG1040483H NG1040628H NG1040637H NG1040667H NG1040668H NG1040737H NG1040999H NG1041013H NG1041041H NG1041067H NG1041078H NG1041079H NG1041134H NG1041165H NG1041169H NG1041212H NG1041229H NG1041254H NG1041262H NG1043526H NG1043542H NG1043547H NG1043549H NG1043570H NG1043571H NG1043574H NG1043585H NG1043587H NG1043589H NG1043600H NG1043605H NG1043618H NG1043619H NG1043629H NG1043637H NG1043642H NG1043656H NG1043659H NG1048215H NG1051985H NG1051990H NG1052098H NG1054459H NG1054461H NG1055929H NG1055937H NG1055959H NG1055980H NG1055987H NG1056018H NG1056021H NG1056025H NG1057684H NG1057686H NG1057690H NG1059069H NG1059076H NG1059083H NG1059107H NG1059119H NG1059125H NG1059126H NG1059151H NG1059154H NG1059178H NG1059187H NG1059297H NG1059307H NG1059313H NG1059319H NG1059326H NG1059356H NG1059367H NG1059386H NG1059411H NG1059419H NG1059424H NG1059440H NG1060999H NG1066735H NG1066747H NG1066778H NG1066783H NG1066788H NG1066803H NG1066816H NG1066821H NG1066823H NG1066827H NG1066854H NG1066863H NG1066871H NG1066891H NG1066893H NG1066894H NG1066897H NG1066899H NG1066902H NG1066904H NG1066906H NG1066909H NG1066916H NG1068481H NG1068815H NG1068819H NG1068829H NG1068831H NG1068832H NG1068838H NG1068841H NG1068842H NG1068850H NG1068892H NG1073307H NG1073320H NG1073321H NG1073336H NG1073354H NG1073371H NG1073381H NG1073392H NG1073406H NG1073412H NG1073413H NG1073415H NG1076044H NG1076047H NG1076063H NG1076079H NG1076086H NG1076103H NG1076128H NG1076132H NG1076148H NG1076153H NG1076156H NG1076170H NG1076181H NG1076187H NG1076212H NG1076217H NG1082514H NG1082516H NG1082524H NG1082527H NG1082532H NG1082534H NG1082538H NG1082559H NG1082564H NG1082567H NG1082568H NG1082571H NG1082572H NG1082587H NG1082589H NG1082594H NG1082595H NG1082597H NG1082602H NG1082641H NG1082645H NG1082650H NG1082667H NG1082672H NG1082680H NG1082682H NG1082684H NG1082694H NG1082700H NG1082702H NG1082705H NG1082737H NG1082739H NG1082741H NG1084306H NG1084330H NG1084341H NG1084348H NG1084350H 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NG1192060H NG1192104H NG1192115H NG1192128H NG1192140H NG1192145H NG1192147H NG1192158H NG1192160H NG1192161H NG1192162H NG1192165H NG1192170H NG1195230H NG1197048H NG1204061H NG1204075H NG1204090H NG1204107H NG1204112H NG1204116H NG1204120H NG1204130H NG1204131H NG1204137H NG1204139H NG1204628H NG1205370H NG1205704H NG1205712H NG1217864H NG1217872H NG1217883H NG1217891H NG1217892H NG1217893H NG1217899H NG1217900H NG1217904H NG1217912H NG1217923H NG1217944H NG1217952H NG1217953H NG1217957H NG1217966H NG1217972H NG1217984H NG1217998H NG1218011H NG1218029H NG1218037H NG1218041H NG1218051H NG1218073H NG1218080H NG1218081H NG1218087H NG1218090H NG1224836H NG1225113H NG1226007H NG1226994H NG1228066H NG1228072H NG1230937H NG1230969H NG1231486H NG1231493H NG1231753H NG1235372H NG1236922H NG1236932H NG1236940H NG1236947H NG1236956H NG1236958H NG1236960H NG1236967H NG1236982H NG1236983H NG1236984H NG1236988H NG1236990H NG1236991H NG1236999H NG1237001H NG1237004H NG1237010H NG1237014H NG1237017H 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NG1270618H NG1270624H NG1270633H NG1270634H NG1270642H NG1270649H NG1270661H NG1270662H NG1274532H NG1274538H NG1274553H NG1274568H NG1274569H NG1274598H NG1274614H NG1274616H NG1274617H NG1275250H NG1279314H NG1279565H NG1279573H NG1279610H NG1279611H NG1279615H NG1279620H NG1279623H NG1279635H NG1279647H NG1279655H NG1279659H NG1279660H NG1279666H NG1279674H NG1279678H NG1279684H NG1279695H NG1279696H NG1279699H NG1279708H NG1279713H NG1279715H NG1279725H NG1283014H NG1283024H NG1283026H NG1283027H NG1283032H NG1283043H NG1283048H NG1283052H NG1283056H NG1283059H NG1283078H NG1283079H NG1283085H NG1283109H NG1283110H NG1283114H NG1283115H NG1283119H NG1283121H NG1283126H NG1284382H NG1286292H NG1286297H NG1286300H NG1286305H NG1286313H NG1286321H NG1286323H NG1286347H NG1286350H NG1286355H NG1286362H NG1286371H NG1286379H NG1286380H NG1286383H NG1286385H NG1286395H NG1286400H NG1286403H NG1286405H NG1286409H NG1286410H NG1286418H NG1286425H NG1286433H NG1290705H NG1292792H NG1292794H NG1292799H NG1292800H NG1292802H NG1292806H NG1292807H NG1292808H NG1292809H NG1292819H NG1292826H NG1292827H NG1292836H NG1292841H NG1292848H NG1292863H NG1292873H NG1292875H NG1292886H NG1292905H NG1292914H NG1292916H NG1292921H NG1292924H NG1292926H NG1292930H NG1292934H NG1293219H NG1301055H NG1301070H NG1301078H NG1301080H NG1301091H NG1301096H NG1301103H NG1301105H NG1307875H NG1312042H NG1325956H NG1325996H NG1326028H NG1326032H NG1326036H NG1326039H NG1326041H NG1326052H NG1326075H NG1326083H NG1326099H NG1326114H NG1326122H NG1326128H NG1326130H NG1326131H NG1326141H NG1326148H NG1326150H NG1326151H NG1326155H NG1326165H NG1326203H NG1326206H NG1326227H NG1326228H NG1326229H NG1326232H NG1326235H NG1326236H NG1326840H NG1326900H NG1327305H NG1327613H NG1334413H NG1334420H NG1334422H NG1334424H NG1334425H NG1334429H NG1334435H NG1334436H NG1334439H NG1334441H NG1334464H NG1334479H NG1334480H NG1334481H NG1334482H NG1334486H NG1334489H NG1334512H NG1334520H NG1334530H NG1334534H 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NG2834622H NG2834631H NG2834634H NG2834640H NG2834644H NG2834647H NG2834652H NG2834654H NK5001796H NK5001801H NK5001805H NK5001812H NK5001817H NK5001818H NK5001820H NK5001821H NK5001823H NK5001846H NK5001849H NK5001852H NK5001853H NK5001859H NK5001883H NK5001884H NK5001885H NK5001887H NK5001889H NK5001890H NK5001891H NK5001894H NK5001902H NK5001904H NK5001906H NK5001913H NK5001986H NK5001991H NK5002091H NK5002092H NK5002104H NK5002112H NK5002140H NK5002146H NK5002154H NK5002158H NK5002164H NK5002168H NK5002170H NK5002173H NK5002174H NK5002243H NK5002251H NK5002260H NK5002280H NK5002281H NK5002312H NK5002321H NK5002348H NK5002412H NK5005055H NK5005076H NK5005085H NK5005088H NK5005089H NK5005090H NK5005091H NK5005092H NK5005116H NK5005117H NK5005121H NK5005356H NK5005365H NK5005367H NK5005368H NK5005375H NK5005385H NK5005386H NK5005387H NK5005859H NK5006032H NK5006044H NK5006045H NK5006049H NK5006082H NK5006097H NK5006846H NK5007563H NK5007564H NK5007597H NK5007610H NK5007617H NK5007642H NK5007643H NK5009160H NK5009172H NK5009177H NK5009344H NK5009358H NK5009361H NK5009365H NK5009371H NK5009375H NK5009389H NK5009390H NK5009391H NK5009392H NK5009399H NK5009415H NK5009426H NK5009478H NK5009772H NK5009774H NK5009813H NK5010156H NK5010172H NK5010344H NK5010362H NK5010363H NK5010364H NK5010373H NK5010396H NK5010399H NK5010407H NK5010414H NK5010419H NK5010433H NK5010434H NK5010435H NK5010436H NK5010467H NK5010751H NK5010969H NK5010975H NK5010988H NK5011007H NK5011008H NK5011011H NK5011012H NK5011025H NK5011026H NK5011027H NK5011351H NK5011358H NK5011457H NK5011459H NK5011462H NK5011588H NK5011897H NK5013814H NK5013819H NK5014606H NK5014653H NK5014678H NK5014688H NK5014706H NK5014720H NK5014721H NK5015607H NK5015610H NK5015624H NK5015629H NK5015652H NK5015653H NK5015670H NK5015672H NK5015726H NK5015728H NK5016288H NK5016296H NK5016297H NK5016309H NK5016337H NK5016343H NK5016391H NK5018596H NK5018604H NK5018626H NK5018763H NK5018765H NK5019916H NK5020781H NK5020802H NK5020803H NK5020862H NK5020863H NK5021061H NK5021064H NK5021181H NK5021201H NK5021209H NK5021442H NK5021446H NK5021449H NK5021456H NK5021458H NK5021482H NK5021504H NK5021524H NK5021540H NK5021551H NK5021553H NK5021554H NK5021555H NK5021574H NK5021579H NK5021919H NK5021931H
Recalling Firm/
Manufacturer		 Medtronic MiniMed
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Medtronic Diabetes Technical Support
800-646-4633 Ext. 1
Manufacturer Reason
for Recall		 Due to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a loss of power/functionality of the insulin infusion pumps.
FDA Determined
Cause 2		 Device Design
Action On 05/24/2022, Medtronic began communicating an "URGENT MEDICAL DEVICE CORRECTION" Letter to customers informing them of the battery cap issue where if the metal contact becomes loose or falls off from the battery cap, it can result in an incomplete battery connection, leading to no power source to the insulin pump. Actions Required by customers: Before beginning: Do not remove the battery cap unless you have a new battery available. If you have a spare undamaged battery cap, ensure it is available nearby. During routine battery replacement, check the metal contact on your pump battery cap to see if it is loose, damaged, or missing. You can view animated instructions on how to inspect the battery cap contact through our website at www.medtronicdiabetes.com/battery-cap-guide. " If the battery cap contact is damaged, immediately replace it with a spare cap that you received with original pump shipment, and discard the damaged cap. If no spare cap, stop using pump and revert to a back-up plan per healthcare provider s recommendations. Then, request a spare battery cap online at www.medtronicdiabetes.com/battery-cap-form, or contact Medtronic 24-Hour Technical Support at 877-496-7933. " If unsure that the battery cap contact are damaged, replace it with a spare cap or request a spare battery cap online at www.medtronicdiabetes.com/battery-cap-form, or contact Medtronic 24-Hour Technical Support at 877-496-7933. " If the battery cap contact is not damaged, continue to use your pump and monitor for cap damage during battery replacement, and complete and return the attached confirmation form by mail. Medtronic will send you a spare cap in the coming months. " Always pay close attention to the pump and pump battery status after inserting the new battery. For questions, contact Medtronic 24-Hour Technical Support at 877-496-7933.
Quantity in Commerce 2,287 pumps
Distribution U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY O.U.S.: Not provided
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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