Data / Medical devices / United States / Medtronic Minimed
Medtronic Minimed: FDA-registered device maker in Northridge, CA, United States, 38 510(k) clearances and 8 PMA approvals
Medtronic Minimed is registered with the FDA (registration 2032227) in Northridge, CA, United States. It lists 24 device types. The FDA files 38 510(k) clearances and 8 PMA approvals under its listings, the newest dated March 12, 2026. 62 recall events name it as the recalling firm (4 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2032227
- FEI number
- 3003166194
- Address
- 18000 Devonshire St, Northridge, CA, United States, 91325
- Owner or operator
- Medtronic (10094334)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- July 26, 2005
- Registered through
- 2027
- Brand names listed
- App Manager, CSS7100 GUARDIAN REAL-TIME MONITOR, CSS7100k GUARDIAN REAL-TIME MONITOR, CSS72 Guardian REAL-Time Continuous Glucose Monitoring System, CSS7200 Guardian Connect App, CSS7200 Guardian Connect App iOS Platform, CSS7201 Guardian Connect App Android Platform, CSS73 Guardian REAL-Time Continuous Glucose Monitoring System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Pump, Infusion | MRZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Alternate Controller Enabled Insulin Infusion Pump | QFG | 2 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Automated Insulin Dosing , Threshold Suspend | OZO | 3 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Automated Insulin Dosing Device System, Single Hormonal Control | OZP | 3 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Calculator, Drug Dose | NDC | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Continuous Glucose Monitor Retrospective Data Analysis Software | PHV | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Continuous Glucose Monitor Secondary Display | PJT | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Manufacturer for export | accessdata.fda.gov |
| Insulin Pump Secondary Display | PKU | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Interoperable Automated Glycemic Controller | QJI | 2 | Manufacturer | accessdata.fda.gov |
| Interoperable Automated Glycemic Controller, Insulin Suspend | QJS | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Syringe Needle | KZH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Infusion, Implanted, Programmable | LKK | 3 | Manufacturer for export | accessdata.fda.gov |
| Pump, Infusion, Insulin | LZG | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor | OYC | 3 | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Sensor, Glucose, Invasive | MDS | 3 | Complaint file establishment, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System | SFI | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Sensor, Glucose, Invasive, Non-Adjunctive | PQF | 3 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Specification developer | accessdata.fda.gov |
| Tubing, Fluid Delivery | FPK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 12, 2026 | K253743 | MiniMed Flex pump | QFG | Substantially Equivalent | Medtronic Minimed, Inc. | accessdata.fda.gov |
| February 3, 2026 | K253701 | SmartGuard Technology; Predictive Low Glucose Technology | QJI | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
| January 15, 2026 | K253470 | MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) | QFG | Substantially Equivalent | Medtronic Minimed, Inc. | accessdata.fda.gov |
| January 14, 2026 | K253585 | SmartGuard technology; Predictive Low Glucose technology | QJI | Substantially Equivalent | Medtronic Minimed, Inc. | accessdata.fda.gov |
| January 8, 2026 | K253512 | MiniMed Go App | NDC | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
| August 29, 2025 | K251217 | SmartGuard technology; Predictive Low Glucose technology | QJI | Substantially Equivalent | Medtronic Minimed, Inc. | accessdata.fda.gov |
| July 1, 2025 | K251032 | MiniMed 780G insulin pump | QFG | Substantially Equivalent | Medtronic Minimed, Inc. | accessdata.fda.gov |
| November 12, 2024 | K242775 | InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) | NDC | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
| April 6, 2022 | K210714 | Extended Reservoir | LZG | Substantially Equivalent | Medtronic Minimed, Inc. | accessdata.fda.gov |
| June 18, 2020 | K201337 | InPen System | NDC | Substantially Equivalent | Companion Medical, Inc. | accessdata.fda.gov |
| February 18, 2020 | K190487 | InPen Dose Calculator | NDC | Substantially Equivalent | Companion Medical, Inc. | accessdata.fda.gov |
| February 10, 2020 | K192841 | InPen System | NDC | Substantially Equivalent | Companion Medical, Inc. | accessdata.fda.gov |
| July 6, 2018 | K181327 | InPen Dose Calculator | NDC | Substantially Equivalent | Companion Medical, Inc. | accessdata.fda.gov |
| September 22, 2016 | K160860 | MiniMed Quick-serter | KZH | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
| August 10, 2016 | K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® | FPA | Substantially Equivalent | Unomedical A/S | accessdata.fda.gov |
| July 26, 2016 | K160629 | InPen | FMF | Substantially Equivalent | Companion Medical, Inc. | accessdata.fda.gov |
| May 19, 2015 | K151236 | MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal) | PJT | Substantially Equivalent | Medtronic Minimed, Inc. | accessdata.fda.gov |
| July 9, 2010 | K100432 | POLYFIN INFUSION SET, MODELS MMT-165, MMT-365, MMT-366, MMT-312S AND MMT-312L AND SOF-SET INFUSION SETS | FPA | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
| October 17, 2007 | K070438 | MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 | MRZ | Substantially Equivalent | Medtronic Minimed, Inc. | accessdata.fda.gov |
| January 31, 2006 | K053177 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E | LZG | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
| July 19, 2004 | K041318 | MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP | LZG | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
| June 30, 2004 | K041545 | CONTACT DETACH | FPA | Substantially Equivalent | Unomedical A/S | accessdata.fda.gov |
| May 21, 2004 | K040676 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715 | LZG | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
| November 18, 2003 | K031541 | PARADIGMPAL, MODEL MMT-7330 | LZG | Substantially Equivalent | Minimed, Inc. | accessdata.fda.gov |
| October 9, 2003 | K032854 | UNOMEDICAL MONICA INFUSION SET | FPA | Substantially Equivalent | Unomedical A/S | accessdata.fda.gov |
| August 22, 2003 | K032005 | MEDTRONIC MINIMED PARADIGM RESERVOIR, MODEL MMT-332 | FRN | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
| August 6, 2002 | K021974 | MEDTRONIC MINIMED COMLINK, HARDWARE MODEL 7304 & SOFTWARE MODEL 7311 | MRZ | Substantially Equivalent | Minimed, Inc. | accessdata.fda.gov |
| June 7, 2001 | K011071 | PARADIGM QUICK-SET INFUSION SET | FPA | Substantially Equivalent | Maersk Medical A/S | accessdata.fda.gov |
| April 5, 2001 | K010377 | MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385 | KZH | Substantially Equivalent | Minimed, Inc. | accessdata.fda.gov |
| August 29, 2000 | K002138 | PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380 | FPA | Substantially Equivalent | Maersk Medical A/S | accessdata.fda.gov |
| August 18, 2000 | K001829 | MINIMED PARADIGM INSULIN PUMP, MODEL 511 | FRN | Substantially Equivalent | Minimed, Inc. | accessdata.fda.gov |
| August 18, 2000 | K001828 | PARADIGM 1.5ML RESERVOIR, MODEL 326 | FRN | Substantially Equivalent | Minimed, Inc. | accessdata.fda.gov |
| January 18, 2000 | K991936 | 3.0 ML RESERVOIR, MODEL 103/193 | FRN | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
| July 29, 1999 | K992300 | QUICK-SERTER, MODEL 395 | KZH | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
| June 25, 1999 | K991759 | MAERSK MEDICAL CONTOUR INFUSION SET | FPA | Substantially Equivalent | Maersk Medical A/S | accessdata.fda.gov |
| June 8, 1999 | K990801 | MINIMED 508 INSULIN PUMP | LZG | Substantially Equivalent - Subject to Tracking Reg. | Medtronic Minimed | accessdata.fda.gov |
| August 26, 1997 | K972135 | MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET | FPA | Substantially Equivalent | P/L Biomedical | accessdata.fda.gov |
| March 31, 1997 | K970479 | MINIMED SOF-SERTER INFUSION SET INSERTION SYSTEM, MODEL 300 | KZH | Substantially Equivalent | Medtronic Minimed | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 6, 2025 | P250012 | Simplera Sync Sensor, Guardian 4 Sensor | SFI | 11 | July 21, 2026 | accessdata.fda.gov |
| March 8, 2018 | P160007 | Guardian Connect system | MDS | 55 | July 21, 2026 | accessdata.fda.gov |
| September 28, 2016 | P160017 | MiniMed 670G System | OZP | 126 | September 29, 2026 | accessdata.fda.gov |
| August 10, 2016 | P150001 | MINIMED 630G SYSTEM WITH SMARTGUARD(TM) | OZO | 100 | July 21, 2026 | accessdata.fda.gov |
| June 17, 2016 | P150029 | IPRO2 CGM SYSTEM WITH ENLITE SENSOR | MDS | 36 | April 29, 2022 | accessdata.fda.gov |
| December 7, 2015 | P150019 | PARADIGM REAL-TIME REVEL SYSTEM | MDS | 61 | April 29, 2022 | accessdata.fda.gov |
| September 26, 2013 | P120010 | MINIMED 530G SYSTEM | OZO | 135 | July 21, 2026 | accessdata.fda.gov |
| June 15, 1999 | P980022 | CONTINUOUS GLUCOSE MONITORING SYSTEM | MDS | 186 | August 14, 2019 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 11, 2026 | 99765 | Class II | Ongoing | CareLink Clinic, REF: MMT-7350 | CareLink Clinic software version 4.4A includes a software defect in the Settings Calculator feature in which the calculation logic fails to use custom values entered by healthcare professionals (HCPs) for Total Daily Dose (TDD) or Long-acting insulin when calculating the Carb Ratio, Insulin Sensitivity Factor (ISF), and Max Recommended value for Rapid-acting | accessdata.fda.gov |
| September 2, 2026 | 99945 | Class II | Ongoing | Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1 Product Description: The MiniMed Go app for iOS or MiniMed Go ap | A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating their app to version 1.2.1. The long-acting dose reminder is an optional feature that, when enabled, triggers a notification at the scheduled | accessdata.fda.gov |
| August 20, 2026 | 99818 | Class II | Ongoing | Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump intended for the subcuta | Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users potentially have one or more of the following issues: inoperable pump at setup, lack of protection f | accessdata.fda.gov |
| July 13, 2026 | 99374 | Class II | Ongoing | MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712 | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis. | accessdata.fda.gov |
| June 16, 2026 | 99228 | Class II | Ongoing | MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) | For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hypergl | accessdata.fda.gov |
| May 27, 2026 | 99207 | Class II | Ongoing | MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896 | A software anomaly can occur when the pump is paired with the Instinct sensor. Under certain circumstances, the pump unexpectedly stops delivering insulin and displays two error messages back-to-back: Pump Error 53 followed immediately by Pump Error 23. Insulin delivery will stop which may lead to delayed therapy and an increased risk of hyperglycemia or dia | accessdata.fda.gov |
| February 13, 2026 | 98186 | Class II | Ongoing | MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782) | 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, | accessdata.fda.gov |
| January 30, 2026 | 98444 | Class II | Ongoing | 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). | accessdata.fda.gov |
| November 13, 2025 | 97904 | Class II | Ongoing | InPen App, Model/CFN Number: MMT-8061 (Android Users) | When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed | accessdata.fda.gov |
| November 2, 2025 | 97997 | Class II | Ongoing | MiniMed 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 insuli | 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. | accessdata.fda.gov |
| October 21, 2025 | 97873 | Class II | Ongoing | CareLink Clinic, REF: MMT-7350 | Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia. | accessdata.fda.gov |
| June 16, 2025 | 97237 | Class II | Ongoing | InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) | Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate | accessdata.fda.gov |
| May 7, 2025 | 96745 | Class II | Ongoing | Medtronic, Simplera Sensor, REF: MMT-5100JD1 | The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection. | accessdata.fda.gov |
| March 4, 2025 | 96421 | Class II | Ongoing | InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA | Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia. | accessdata.fda.gov |
| January 31, 2025 | 96200 | Class II | Ongoing | Paradigm REF: MMT-712 and MMT-715 | All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered men | accessdata.fda.gov |
| July 31, 2024 | 95121 | Class I | Ongoing | MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851 | Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the de | accessdata.fda.gov |
| November 15, 2023 | 93675 | Class II | Ongoing | Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3 | Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery | accessdata.fda.gov |
| November 21, 2022 | 91260 | Class II | Ongoing | Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system | An app, part of a continuous glucose monitoring system, for use with smartphone devices may automatically log out from CareLink, then the app is not able to upload data. When logged out, linked care partners will not receive SMS notifications (could result in hypoglycemia or hyperglycemia), and sensor glucose values will also not be sent to the InPen app. | accessdata.fda.gov |
| September 20, 2022 | 90910 | Class II | Ongoing | Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782, MMT-1760, MMT-1761, MMT-1762, MMT-1740, MMT-1741, MMT-1742 | Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that could allow unauthorized access to the pump system. This unauthorized access could be used to deliver too much or too little insulin through delivery of an unintended insulin bolus or because insulin delivery is sl | accessdata.fda.gov |
| May 23, 2022 | 90370 | Class II | Ongoing | MiniMed 620G Insulin Pump (O.U.S. version) | 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. | accessdata.fda.gov |
| January 27, 2022 | 89653 | Class II | Ongoing | MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892 | New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do not realize this will receive no basal insulin, which can lead to insulin under-delivery. Insulin under-delivery can cause severe hyperglycemi | accessdata.fda.gov |
| March 15, 2021 | 87735 | Class II | Ongoing | MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886 MM780G 6.5W BLE MG; KIT MMT-1895WW MM780G 6.5V BLE SF MMOL; KIT MMT-1896WW MM780G 6.5W BLE SF MG; PUMP MMT-1884XC 780G V6.5 CLIN US MG; | Due to a software design issue, under certain conditions, a software fault is detected when a large bolus delivery at quick bolus speed completes. if the user is not aware of the amount of active insulin and delivers an additional bolus, there is a risk of insulin over delivery. | accessdata.fda.gov |
| February 26, 2021 | 87476 | Class II | Ongoing | Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - | Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings. | accessdata.fda.gov |
| November 12, 2020 | 86895 | Class II | Ongoing | CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000 | Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software. | accessdata.fda.gov |
| July 15, 2020 | 86081 | Class II | Terminated | The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device. | As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website. | accessdata.fda.gov |
| April 30, 2020 | 85711 | Class II | Ongoing | MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and | Missing solder battery connection, which could interrupt power of insulin pump. | accessdata.fda.gov |
| April 10, 2020 | 85582 | Class II | Terminated | Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001 | Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than allowed endotoxin levels, patients may have an effect of fever, hypotension, anaphylactic shock, hyperglycemia, or diabetic ketoacidosis (DKA), potentially followed by secondary multi-organ failure (primarily renal | accessdata.fda.gov |
| November 21, 2019 | 84430 | Class I | Ongoing | Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only | There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglyc | accessdata.fda.gov |
| June 27, 2019 | 83433 | Class II | Ongoing | MiniMed Insulin Pump, model # MMT-508 | The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorized person could potentially connect wirelessly to a nearby insulin pump to change settings and control insulin delivery. | accessdata.fda.gov |
| May 20, 2019 | 85091 | Class II | Ongoing | Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices. | Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) after a full charge. | accessdata.fda.gov |
| October 3, 2018 | 81246 | Class II | Ongoing | Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International) | Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts. | accessdata.fda.gov |
| August 7, 2018 | 82078 | Class I | Terminated | Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508). | There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps. | accessdata.fda.gov |
| July 4, 2018 | 81656 | Class II | Terminated | Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices. | The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events. | accessdata.fda.gov |
| May 16, 2018 | 80685 | Class II | Terminated | Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose monitoring system (glucometer, test strips and control solution) is designe | CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. This meter contains the incorrect unit of measure mg/dL instead of mmol/L. | accessdata.fda.gov |
| April 24, 2018 | 80320 | Class II | Terminated | Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754 | The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting screen, which allows user to program alerts that will sound if users are predicted to reach their pre-set low or high sensor glucose values. | accessdata.fda.gov |
| October 10, 2017 | 78298 | Class II | Terminated | Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and provid | Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result in incorrect reports. This pertains only to reports generated between September 23, 2017 and September 27, 2017 that used the new CareLink iPro Uploader feature. | accessdata.fda.gov |
| September 10, 2017 | 78125 | Class II | Ongoing | Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T) | Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. | accessdata.fda.gov |
| May 8, 2017 | 77188 | Class II | Terminated | MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750. | Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive. | accessdata.fda.gov |
| January 31, 2017 | 76436 | Class II | Terminated | MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these insulin pumps are MMT-1510, MMT-1710, MMT-1711, MMT-1712. | Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it leads to battery depletion and pump shutdown. | accessdata.fda.gov |
| August 5, 2016 | 74955 | Class II | Terminated | CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous gl | Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error. | accessdata.fda.gov |
| February 19, 2016 | 73451 | Class II | Terminated | CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuous glucose information | Medtronic MiniMed is recalling 19 CareLink iPro Therapy Management reports because the CareLink iPro reports were created using the Pacific Standard Time zone as the time reference, although the patients and their sensor data were subject to the Central Standard Time zone. The CareLink iPro2 Professional CGM (continuous glucose monitor) data uploading error | accessdata.fda.gov |
| September 25, 2015 | 72352 | Class II | Terminated | MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitu | The pump drive motors may experience a malfunction which would result in a pump error message alarm notifying you that insulin is no longer being delivered. Possible cause is either lack of greasing or deficient greasing in a ball bearing assembly of the motor. | accessdata.fda.gov |
| July 22, 2015 | 71816 | Class II | Terminated | Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of impr | Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifically, the Monitor has a Finnish translation error in Predictive Alerts setting: the on-screen Finnish translation for LOW/HIGH is reversed as HIGH/LOW. | accessdata.fda.gov |
| June 19, 2015 | 70897 | Class II | Terminated | MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511; NGP 640G 1.8ml (mg/dL), Model No. 1512; NGP 640G PLGM 3ml (mmol/L), Model No. MMT-1711; NGP 640G PLGM 3ml (mg/dL), Model No. MMT-1712. | Medtronic MiniMed is recalling the MiniMed 620G and 640G insulin pumps because there are certain scenarios where the set Bolus screen will not timeout, which could cause confusion by showing a bolus amount that is no longer appropriate. | accessdata.fda.gov |
| November 10, 2014 | 70424 | Class III | Terminated | CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MM | The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pump. | accessdata.fda.gov |
| November 4, 2014 | 69720 | Class II | Terminated | Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets; Paradigm Silhouette infusion sets: MMT-368, MMT-368600, MMT-371, MMT-373, MMT-377, MMT-377600, MMT378, MMT-378600, MMT-38 1, MMT-381 600, MMT-382, MMT-382 | Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted insulin delivery and the pump will not alarm to notify your patient. This can lead to hyperglycemia, and diabetic ketoacidosis (DKA). | accessdata.fda.gov |
| July 21, 2014 | 68888 | Class II | Terminated | Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-se | Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian monitors. | accessdata.fda.gov |
| June 16, 2014 | 68633 | Class II | Terminated | Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D | Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a pump malfunction resulting in the disconnection of the delivery of insulin prior to the end of the 7 year useful life of the device. | accessdata.fda.gov |
| March 13, 2014 | 68277 | Class II | Terminated | Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. | Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion Pumps because they have received reports that users have accidentally programmed the pump to deliver the maximum bolus amount. | accessdata.fda.gov |
| July 3, 2013 | 65644 | Class II | Terminated | Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion | Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and MMT-332A (3.0mL) used with Medtronic Paradigm insulin pumps because they may have increased risk for leaking. A leak in the reservoir may result in delivery of less insulin than intended. In addition, if there is a leaky reservoir and an insulin blockage occurs | accessdata.fda.gov |
| June 7, 2013 | 65430 | Class I | Terminated | Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps. | Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect | accessdata.fda.gov |
| March 22, 2013 | 64754 | Class II | Terminated | Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. Pr | Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap may become detached from the pump case and protrude from the lower right side of the pump. When the pump is expose to water it may result in damage to the pump's internal electronics. This moisture damage can prevent the pump's buttons from working properly or can | accessdata.fda.gov |
| May 16, 2011 | 59960 | Not yet classified | Terminated | Medtronic MiniMed paradigm mio Infusion Sets MMT-921 The Paradigm mio infusion sets are intended for the subcutaneous infusion of insulin from a Medtronic MiniMed Paradigm insulin infusion pum. | The consignee received four (4) boxes of mio infusion sets (MMT-921) that were shipped to them in error. These infusion sets were shipped in a package that included a MiniMed Paradigm REAL-TIME Insulin Pump among other items. The mio infusion sets were not authorized to be shipped to the consignee based on Medtronics internal product handling procedures and | accessdata.fda.gov |
| June 29, 2009 | 52521 | Not yet classified | Terminated | Paradigm Quick-set Infusion Sets, Models MMT-396, MMT-397, MMT-398 and MMT-399. The Paradigm Quick-set infusion sets are intended for use in combination with Paradigm reservoirs (models MMT- 326 or MMT-332) and Paradigm | Approximately 2% of the infusion sets in the affected lots may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the syringe compartment with the surrounding atmosphere. If the vent does not work properly, this could potentially result in too much or too little insulin being delivered. | accessdata.fda.gov |
| April 27, 2007 | 37944 | Not yet classified | Terminated | Medtronic MiniMed Paradigm Insulin Infusion Pumps for the following Paradigm models: MMT-511, MMT-512, MMT-712, MMT-515, MMT-715, MMT-522 and MMT-722 | Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were alarms as a result of the damage, some users cleared these alarms and continued using the pump. Under such conditions, the pump will significantly over-deliver | accessdata.fda.gov |
| April 27, 2005 | 33025 | Not yet classified | Terminated | ''Fine Tuning Your Pump'' booklet provided with Model MMT-515 AND MMT-715 INSULIN INFUSION PUMPS | The text description of how to perform insulin sensitivity testing and associated worksheet included in the booklet that is shipped with the Paradigm 515 and Paradigm 715 insulin pumps contained a basic flaw in that the blood glucose after the correction should be compared to the target glucose and it says compare to the beginning blood glucose in the proced | accessdata.fda.gov |
| September 14, 2004 | 30059 | Not yet classified | Terminated | Medtronic MiniMed Paradigm Model 712 | Several complaints of pumps exhibiting A47 alarms were received. Investigation revealed the alarms occurred when the pump attempted to display text that exceeded the maximum display length of the pump screen. The investigation revealed this only occurs when the pump is programmed to display information in Spanish. | accessdata.fda.gov |
| March 2, 2004 | 35768 | Not yet classified | Terminated | Medtronic MiniMed Paradigm Quick-set Plus Infusion Sets. Models MMT-359S6; MMT-359S9; MMT359L6; & MMT-359L9. (differences in models is variation in length, 6 versus 9mm) | Possibility of interrupted insulin flow. This posting is for a recall that occurred in March 2004, also posted on the FDA website in 2004. | accessdata.fda.gov |
| January 28, 2004 | 28214 | Not yet classified | Terminated | Medtronic MiniMed Model 7311 Version 5.0B Solutions Pumps and Meters Software. | A minor software anomaly results in an error in the calculation of the average glucose range that appears on one of the reports available in the model 7311 software. | accessdata.fda.gov |
| November 19, 2003 | 27740 | Not yet classified | Terminated | Medtronic MiniMed Model 7311Version 5.0A Solutions Pumps and Meters Software | Accessory software fails to report certain reports following download of data from 712 pump. | accessdata.fda.gov |
| September 9, 2003 | 27475 | Not yet classified | Terminated | Ambulatory infusion pump. Model 511 | Non delivery of insulin by pump after electrostatic discharge. | accessdata.fda.gov |
| August 29, 2003 | 27474 | Not yet classified | Terminated | Paradigm Model 511 and 512 Insulin Infusion Pumps | Water ingresses into the device when in prolonged contact with water causing device to malfunction. | accessdata.fda.gov |
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Updated October 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.