Reported Apr 8, 2026 · Ongoing
Paradigm Insulin Pump (MMT-712, MMT-715)
Medtronic MiniMed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic MiniMed, Inc. · 18000 Devonshire St · Northridge, CA · 91325-1219
Is this the product you have?
Paradigm Insulin Pump (MMT-712MMT-715)
- Lot codes and dates
8 of 8 products
Products covered by this recall # Barcodes Product as published 1 643169999770643169729360763000065201763000069001763000192228763000198602763000155346763000192143763000258344763000317140763000404567763000317188763000317195763000367046763000317157006139944704920064316949626264316957766464316957768864316957769564316973951200613994332929006139944696940061399447090400763000084271007630001610196431695777016431697395126431696626120064316953377600763000084370643169656840763000090197763000190439763000316631006139944738200064316947850300613994151766006431697103680076300016105700613994326478006139943265080061399439577100613994395719006139943956960061399452785100643169729421006431691989200064316957244700643169198890006139945278680061399417212900613994172419006139941716270061399417134400613994172211006139941725250061399417233400613994172044006139941727610061399417191700613994326621006139943265840064316984882500643169848832006431698488010061399439581800613994395764006139943957400061399439413200763000069209007630000691790061399452790500763000069162006139945277690061399440587600763000069186007630000691480061399452778300613994527806006139945278990061399452779000613994527882006139945278370064316919896800643169198883006431691989440064316919890600763000084301006139945277450064316919897500643169035515006431692019270064316919891300643169198937006139944752680064316919899900643169198982006431695031200076300018750700643169198951006431698488180064316984879500643169848771006139945277380061399417144300613994171528006139943265390061399432656000613994395726006139943957570076300010261600763000069155006139944738680076300000426200763000084318007630001610647630003166550376300031665564316965684076300036705376300009019776300016651976300007252076300019043976300031665501763000316631763000256807UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Insulin Pump: 643169999770, 643169729360, 763000065201, 763000069001, 763000192228, 763000198602, 763000155346, 763000192143, 763000258344, 763000317140, 763000404567, 763000317188, 763000317195, 763000367046, 763000317157, 00613994470492, 00643169496262, 643169577664, 643169577688, 643169577695, 643169739512, 00613994332929, 00613994469694, 00613994470904, 00763000084271, 00763000161019, 643169577701, 643169739512, 643169662612, 00643169533776, 00763000084370, 643169656840, 763000090197, 763000190439, 763000316631, 00613994473820, 00643169478503, 00613994151766, 00643169710368, 00763000161057, 00613994326478, 00613994326508, 00613994395771, 00613994395719, 00613994395696, 00613994527851, 00643169729421, 00643169198920, 00643169572447, 00643169198890, 00613994527868, 00613994172129, 00613994172419, 00613994171627, 00613994171344, 00613994172211, 00613994172525, 00613994172334, 00613994172044, 00613994172761, 00613994171917, 00613994326621, 00613994326584, 00643169848825, 00643169848832, 00643169848801, 00613994395818, 00613994395764, 00613994395740, 00613994394132, 00763000069209, 00763000069179, 00613994527905, 00763000069162, 00613994527769, 00613994405876, 00763000069186, 00763000069148, 00613994527783, 00613994527806, 00613994527899, 00613994527790, 00613994527882, 00613994527837, 00643169198968, 00643169198883, 00643169198944, 00643169198906, 00763000084301, 00613994527745, 00643169198975, 00643169035515, 00643169201927, 00643169198913, 00643169198937, 00613994475268, 00643169198999, 00643169198982, 00643169503120, 00763000187507, 00643169198951, 00643169848818, 00643169848795, 00643169848771, 00613994527738, 00613994171443, 00613994171528, 00613994326539, 00613994326560, 00613994395726, 00613994395757, 00763000102616, 00763000069155, 00613994473868, 00763000004262, 00763000084318, 00763000161064, 76300031665503, 763000316655, 643169656840, 763000367053, 763000090197, 763000166519, 763000072520, 763000190439, 76300031665501, 763000316631, 763000256807: INSTR,US,FINE TUNING,PUMP,512/712 (6024948-012 3) 2 INSTR,US,FINE TUNING,PUMP,PRDGM (6024948-013 1) 3 INSTR,EN,FINE TUNING,PUMP (6024948-021 3) 4 INSTR,US,PUMPS,PRDGM,515/715 (6025020-017 1) 5 INSTR., 515/715, PRDGM, US (6025020-018 2) 6 INSTR, 515/715, MDD, EN (6025020-024 1) 7 INSTR, 515/715, EURO-E, MDD (6025020-025 2) 8 INSTR., X15, EN OUS (6025020-026 1) - Amount recalled
- 73,656
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
This product could cause temporary or reversible health problems — stop using it.
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