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U.S. Department of Health and Human Services

Class 2 Device Recall MiniMed 780G

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 Class 2 Device Recall MiniMed 780Gsee related information
Date Initiated by FirmNovember 02, 2025
Date PostedFebruary 02, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1238-2026
Recall Event ID 97997
510(K)NumberK251032 
Product Classification Automated insulin dosing device system, single hormonal control - Product Code OZP
ProductMiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values.
Code Information MiniMed 780G MMT-1884 (US) UDI-DI codes: 00199150003686 00763000414344 00763000545604 00763000578640 00763000586195 00763000640095 00763000758547 00763000819378 00763000819385 00763000819392 00763000865665 00763000924089 00763000924102 00763000924119 76300075854701 76300081937801 76300081938501 76300096001801 76300096003201 76300096004901 Serial Numbers: NG3666779H NG3811803H NG3926926H NG3944480H NG4116699H NG4173817H NG3334724H NG3750453H NG3874105H NG3924178H NG3926632H NG3927673H NG3944520H NG4023801H NG4029254H NG4097850H NG4146571H NG4170515H NG4200310H NG4177489H NG4178626H NG2752574H NG3423286H NG3838934H NG3926282H NG3948645H NG4017463H NG4010052H NG4174745H NG4178395H NG3502087H NG3634564H NG3756694H NG3871741H NG3919620H NG3927825H NG4164005H NG3729206H NG3839883H NG3884748H NG3908444H NG3961353H NG4068853H NG4179772H NG3106884H NG3116129H NG3271492H NG3351525H NG3458389H NG3464645H NG3490545H NG3482017H NG3520991H NG3593959H NG3515336H NG3467707H NG3563980H NG3654085H NG3653614H NG3662418H NG3631555H NG3686291H NG3685575H NG3721941H NG3722374H NG3751345H NG3762687H NG3773707H NG3804837H NG3785876H NG3815941H NG3809816H NG3809672H NG3809900H NG3811760H NG3857851H NG3848444H NG3865466H NG3871979H NG3923251H NG3928992H NG3946093H NG3944898H NG3945847H NG3966122H NG3925413H NG3984252H NG4071539H NG3891538H NG4099361H NG4097100H NG3966344H NG4115711H NG4170457H NG4170650H NG4171411H NG4179308H NG4165581H NG4166028H NG4174665H NG4176618H NG4197135H NG4198605H NG4194835H NG4213027H NG2811465H NG2922632H NG3050369H NG2473989H NG3110782H NG3165546H NG3245352H NG3491506H NG3504053H NG3503998H NG3467406H NG3727425H NG3718393H NG3741705H NG3740402H NG3754549H NG3743216H NG3838750H NG3859322H NG3846048H NG3851889H NG3869122H NG3878439H NG3920428H NG3941436H NG3919322H NG3927745H NG3946295H NG3923212H NG3941150H NG3978427H NG3945129H NG3952217H NG4041650H NG4019446H NG4010956H NG4025469H NG4079778H NG4089972H NG4087937H NG4082944H NG4068836H NG4075347H NG4078121H NG4088929H NG4171211H NG4177285H NG4174489H NG4177168H NG4176329H NG4208285H NG3666827H NG3695566H NG3713071H NG3717692H NG3745851H NG3749951H NG3735248H NG3774228H NG3848457H NG3848901H NG3849344H NG3855096H NG3874209H NG3891021H NG3878609H NG3872267H NG3892797H NG3925816H NG3944275H NG3938415H NG3934980H NG3978206H NG3997696H NG4023617H NG4067807H NG4068186H NG4068276H NG4097308H NG4086943H NG4127318H NG4116303H NG4168668H NG4170561H NG4177312H NG4187583H NG4200314H NG4188462H NG4194675H NG4196463H NG4193920H NG2983018H NG3226459H NG3253416H NG3375428H NG3389508H NG3455845H NG3290714H NG3544255H NG3496998H NG3664014H NG3665167H NG3741756H NG3781060H NG3851847H NG3874189H NG3873296H NG3904518H NG3923064H NG3920073H NG3941074H NG3978585H NG3946268H NG3963748H NG3950286H NG3998081H NG4068503H NG4066883H NG3890599H NG4102568H NG4104044H NG4117340H NG3998278H NG4127913H NG4171084H NG4174122H NG4174291H NG4182715H NG4186723H NG4187005H NG4176580H NG4195536H NG3458407H NG3473827H NG3477699H NG3613124H NG3651486H NG3727632H NG3732603H NG3732097H NG3742868H NG3762837H NG3761312H NG3813562H NG3822747H NG3857855H NG3922024H NG3920283H NG3924778H NG3951674H NG3940453H NG3985400H NG4018435H NG4060209H NG3900942H NG4102555H NG4124451H NG4174561H NG4174265H NG4163176H NG4182361H NG4164206H NG4186544H NG4208987H NG4209038H NG4209772H NG3163771H NG3411122H NG3458356H NG3491051H NG3567668H NG3544931H NG3713706H NG3718296H NG3809723H NG3818145H NG3809695H NG3864681H NG3887795H NG3679742H NG3924943H NG3922383H NG3919426H NG3940166H NG3941349H NG3944627H NG3956071H NG3956255H NG3944080H NG3957029H NG4016482H NG4023471H NG4028592H NG4001339H NG4041278H NG4090250H NG4068352H NG4102363H NG4127855H NG4132413H NG4169591H NG4177207H NG4188937H NG4196659H NG4198913H NG4185996H NG4194032H NG2961968H NG3183875H NG3364711H NG3485451H NG3659840H NG3723944H NG3760420H NG3851650H NG3873270H NG3873916H NG3919931H NG3919276H NG3922916H NG3944526H NG3944883H NG3967996H NG3997414H NG4027677H NG4068541H NG4074551H NG4007627H NG4090727H NG4166453H NG4174861H NG4186466H NG4185395H NG3382971H NG3481967H NG3467038H NG3810654H NG3809624H NG3847661H NG3873897H NG3924866H NG4019072H NG4041335H NG3999977H NG4090264H NG4165104H NG4163851H NG4213316H NG4194145H NG4208491H NG4213235H NG3485962H NG3663692H NG3759049H NG3927116H NG3946843H NG4102485H NG4086520H NG4171232H NG4182306H NG4188842H NG4194893H NG4185530H NG3147620H NG3184692H NG3353641H NG3548823H NG3564359H NG3588804H NG3659473H NG3685910H NG3748805H NG3814075H NG3840461H NG3860668H NG3895329H NG3935978H NG3937049H NG3948288H NG3923677H NG4083102H NG4099861H NG4082989H NG4107594H NG4106821H NG4171004H NG4176911H NG4196531H NG3243700H NG3246406H NG3371614H NG3661271H NG3683626H NG3673177H NG3694706H NG3713254H NG3760082H NG3748497H NG3749309H NG3748011H NG3775429H NG3849814H NG3924553H NG3919243H NG3923922H NG3927559H NG3969381H NG3966341H NG4018365H NG4032354H NG4018703H NG4041745H NG4010058H NG4029767H NG4083385H NG4100145H NG4097345H NG4097235H NG4107936H NG4104095H NG4108210H NG4170763H NG4165812H NG4186693H NG4211611H NG4213202H NG4207746H NG3114301H NG3564122H NG3721813H NG3743159H NG3787250H NG3854912H NG3869412H NG3852734H NG3925478H NG3924666H NG3928263H NG3944907H NG4070559H NG4130771H NG4170768H NG4170452H NG4177528H NG4162597H NG4165982H NG4199525H NG4189316H NG4207379H NG4178152H NG4209571H NG4202973H NG4212081H NG4206258H NG4206260H NG3051461H NG3454532H NG3489433H NG3467383H NG3581464H NG3659162H NG3671350H NG3595657H NG3806944H NG3808408H NG3849373H NG3858126H NG3865299H NG3874299H NG3898715H NG3948402H NG3938691H NG4009013H NG4113402H NG4183006H NG4212823H NG2774486H NG3452537H NG3467644H NG3599030H NG3697530H NG3731119H NG3816424H NG3823039H NG3833967H NG3855387H NG3926863H NG3944332H NG3944392H NG4022901H NG4196153H NG4206960H NG3512186H NG4198638H NG3750301H NG4114589H NG4087305H NG3870585H 503 MiniMed 780G MMT-1886 (Israel) UDI-DI code: 76300062988501 Serial Numbers: NG3817434H NG3817435H NG3817215H NG3817216H NG3817231H NG3817236H NG3817243H NG3817441H NG3817375H NG3817390H NG3817436H NG3817253H NG3817401H NG3817208H NG3817252H NG3817256H NG3817320H NG3817370H NG3817388H NG3817408H NG3817249H NG3817296H NG3817312H NG3817374H NG3817389H NG3817227H NG3817242H NG3817250H NG3817255H NG3817300H NG3817302H NG3817204H NG3817207H NG3817248H NG3817406H NG3817463H NG3817480H NG3817482H NG3817393H NG3817415H NG3817425H NG3817438H NG3817319H NG3817419H NG3817233H NG3817247H NG3817289H NG3817292H NG3817201H NG3817212H NG3817245H NG3817251H NG3817437H NG3817485H NG3817487H NG3817491H NG3817257H NG3817494H NG3817409H NG3817431H NG3817440H NG3817481H NG3817445H NG3817483H NG3817220H NG3817240H NG3817428H NG3817439H NG3817448H NG3817378H NG3817403H NG3817424H NG3817430H NG3817432H
FEI Number 3003166194
Recalling Firm/
Manufacturer		 Medtronic MiniMed, Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information ContactMedtronic 24-Hr Technical Support
800-646-4633 Ext. 1
Manufacturer Reason
for Recall		A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
FDA Determined
Cause 2		Process design
ActionOn 11/02/2025, the firm sent an initial "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that an issue was identified which may cause the MiniMed 780G pump to display an alarm indicating insulin delivery is being stopped (Pump error 43 or 41). Customers are instructed to: 1.Respond to all alerts/alarms from your pump. 2.Be prepared to complete the Reservoir & Set procedure after responding to a Pumperror 43 or Pump error 41 alarm. 3.Check that your Alert on High is set during the night or at times when you may not be actively monitoring the pump, making it easier to detect when insulin delivery remains suspended. 4. Keep the pump s audio enabled, making it easier to detect when insulin delivery remains suspended after an alarm is acknowledged. For questions or further assistance, contact Medtronic 24-Hour Technical Support line at 1-800-646-4633, option 1.
Quantity in Commerce577 units
DistributionWorldwide - U.S. National distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The country of Israel.
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = OZP
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