FDA-Device2026-04-01Class II

MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

Medtronic MiniMed, Inc.

Hazard

Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).

Sold states

Worldwide - U.S. Nationwide distribution including in the states of 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Israel.

Affected count

26,851 pumps

Manufactured in

18000 Devonshire St, Northridge, CA, United States

Products

MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1635-2026

Original summary

MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery). MiniMed 780G Model Number: MMT-1884 UDI-DI code: 763000414344 Serial Numbers: NG2445689H NG2445778H NG2455039H NG2461527H NG2461608H NG2471389H NG2471573H NG2472820H NG2473989H NG2480622H NG2481237H NG2488091H NG2489139H NG2489358H NG2493893H NG2494899H NG2496212H NG2496474H NG2497261H NG2499391H NG2499496H NG2500475H NG2500548H NG2501835H NG2502145H NG2502898H NG2507769H NG2507907H NG2508301H NG2508631H NG2508977H NG2511996H NG2513292H NG2521020H NG2522070H NG2523184H NG2530419H NG2531373H NG2531462H NG2531531H NG2532792H NG2533855H NG2535235H NG2535576H NG2537531H NG2538456H NG2540108H NG2541102H NG2541837H NG2543029H NG2544725H NG2548997H NG2550437H NG2570180H NG2570258H NG2570863H NG2576778H NG2579113H NG2579956H NG2580323H NG2580479H NG2583059H NG2583537H NG2586717H NG2589082H NG2590426H NG2603812H NG2603854H NG2604027H NG2611960H NG2612797H NG2614177H NG2617670H NG2617983H NG2629660H NG2635544H NG2636572H NG2637401H NG2642169H NG2644227H NG2644567H NG2647406H NG2647913H NG2648318H NG2649298H NG2656257H NG2656473H NG2657321H NG2657360H NG2658332H NG2659390H NG2659574H NG2697897H NG2697936H NG2698209H NG2698900H NG2705266H NG2706152H NG2710968H NG2712109H NG2714386H NG2718094H NG2723617H NG2724376H NG2724445H NG2742517H NG2742729H NG2742925H NG2742927H NG2745927H NG2748918H NG2748985H NG2749113H NG2749121H NG2749143H NG2750007H NG2750299H NG2751081H NG2751191H NG2752539H NG2752574H NG2753164H NG2753234H NG2753931H NG2754038H NG2760759H NG2760871H NG2761027H NG2761050H NG2761095H NG2761117H NG2761226H NG2761771H NG2762312H NG2762332H NG2772977H NG2773133H NG2773170H NG2773198H NG2773224H NG2773698H NG2774482H NG2774486H NG2774628H NG2775088H NG2775593H NG2775790H NG2775796H NG2776055H NG2776076H NG2776843H NG2777281H NG2777366H NG2777406H NG2777964H NG2778250H NG2778518H NG2791067H NG2810990H NG2811465H NG2851127H NG2852041H NG2852121H NG2852167H NG2852226H NG2852237H NG2852293H NG2852641H NG2852707H NG2853049H NG2853185H NG2853369H NG2853574H NG2853980H NG2854083H NG2854095H NG2854218H NG2854266H NG2868862H NG2869169H NG2869564H NG2870219H NG2870848H NG2871392H NG2871868H NG2872358H NG2872379H NG2873197H NG2879290H NG2880034H NG2880037H NG2880061H NG2880324H NG2892508H NG2909952H NG2910456H NG2910488H NG2910742H NG2910995H NG2911113H NG2911329H NG2911785H NG2911915H NG2912050H NG2912065H NG2912195H NG2912304H NG2912412H NG2912423H NG2912530H NG2912600H NG2912625H NG2912670H NG2912798H NG2916905H NG2917028H NG2917060H NG2917238H NG2917352H NG2917461H NG2917748H NG2917757H NG2917849H NG2917881H NG2918087H NG2918234H NG2918273H NG2918540H NG2918762H NG2918951H NG2919128H NG2919210H NG2921713H NG2921759H NG2921764H NG2921912H NG2921960H NG2922097H NG2922157H NG2922350H NG2922515H NG2922615H NG2922632H NG2922633H NG2922990H NG2923035H NG2923056H NG2923120H NG2923140H NG2923262H NG2923459H NG2923582H NG2923832H NG2923995H NG2924042H NG2924152H NG2941414H NG2941570H NG2941614H NG2941619H NG2941809H NG2941839H NG2941875H NG2942123H NG2942193H NG2942249H NG2942367H NG2942645H NG2942782H NG2943281H NG2943510H NG2943529H NG2943592H NG2951199H NG2951224H NG2951253H NG2951586H NG2951675H NG2951690H NG2951706H NG2951750H NG2951859H NG2952135H NG2952255H NG2952320H NG2952397H NG2952463H NG2952485H NG2952507H NG2952650H NG2953269H NG2953290H NG2953392H NG2953536H NG2953801H NG2953875H NG2953954H NG2953997H NG2954054H NG2954081H NG2954200H NG2954202H NG2955586H NG2955592H NG2955666H NG2955753H NG2955756H NG2955850H NG2955927H NG2955990H NG2955994H NG2956003H NG2956028H NG2956052H NG2956167H NG2956214H NG2956245H NG2956375H NG2956416H NG2956504H NG2956533H NG2956561H NG2956567H NG2956660H NG2956711H NG2956824H NG2956934H NG2956979H NG2960027H NG2960318H NG2960498H NG2960556H NG2960899H NG2960914H NG2961016H NG2961049H NG2961106H NG2961108H NG2961114H NG2961187H NG2961287H NG2961320H NG2961354H NG2961405H NG2961445H NG2961655H NG2961682H NG2961761H NG2961771H NG2961782H NG2961813H NG2961906H NG2961958H NG2961965H NG2961968H NG2961995H NG2962012H NG2962032H NG2968147H NG2968281H NG2968308H NG2968340H NG2968491H NG2968492H NG2968499H NG2968805H NG2968842H NG2968986H NG2969067H NG2969111H NG2969152H NG2969273H NG2969277H NG2969388H NG2969415H NG2969441H NG2969468H NG2969542H NG2969582H NG2969745H NG2980849H NG2980857H NG2980875H NG2980916H NG2981068H NG2981268H NG2981313H NG2981419H NG2981696H NG2981774H NG2981975H NG2981985H NG2982089H NG2982172H NG2982232H NG2982281H NG2982538H NG2982662H NG2982763H NG2982864H NG2982878H NG2982896H NG2982986H NG2983018H NG3001336H NG3001600H NG3001820H NG3001831H NG3001921H

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