MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
type: Dataset
description: FDA recall Z-1635-2026 — Medtronic MiniMed, Inc. is recalling MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
  type: MedicalDevice
  manufacturer: Medtronic MiniMed, Inc.
claims: FDA recall Z-1635-2026: Medtronic MiniMed, Inc. is recalling MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
claims: FDA classified recall Z-1635-2026 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-1635-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-1635-2026
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Medtronic MiniMed, Inc.
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: 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).
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2026-01-30
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 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 NG285408…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: 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.
      status: recorded

FDA recall Z-1635-2026: Medtronic MiniMed, Inc. is recalling MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
type: Claim
text: The FDA logged enforcement record Z-1635-2026: Medtronic MiniMed, Inc. is voluntarily recalling MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61 — reason: 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).. Status: Ongoing — the recall is still being carried out.. Initiated 2026-01-30. Affected lots/codes: 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…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-1635-2026 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.