Northridge, CA, United States
Medtronic MiniMed, Inc. recalls
21 recalls recorded since 2018, most recently on 20 August 2026. 21 are listed as ongoing. Status and classification are as published by the FDA.
Recalls21
Ongoing (FDA)21
Terminated or completed0
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 20 August 2026
- Reason
- 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 for moisture exposure, slow battery charging, disconnection issues with other system components (i.e., continuous glucose monitoring sensor or MiniMed mobile app), reduced ability to detect occlusion events, compromised audio for pump alarms/alerts, and/or inaccurate insulin delivery.
- Distribution
- U.S. Nationwide distribution in the states of AR, AZ, CO, FL, KS, KY, LA, MI, MN, NJ, NY, OH, PA, SD, TN, TX, and WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0088-2027
- 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
Ongoing Class II Medical devices
- Recall started
- 13 July 2026
- Reason
- 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.
- Distribution
- International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2982-2026, Z-2981-2026, Z-2980-2026
- MiniMed 780G Insulin Pump, Model: MMT-1885CLW, MMT-1886CLW
- MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
- MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
Ongoing Class II Medical devices
- Recall started
- 16 June 2026
- Reason
- 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 hyperglycemia.
- Distribution
- Worldwide - US Nationwide distribution in the states and territories of PR, OH, WA, IL, NC, PA, VA, MN, ID, CA, UT, MI, NJ, MS, SC, CO, AZ, OR, AR, MO, TX, AL, FL, NY, IN, TN, IA, WI, MA, LA, OK, GA, KS, NM, CT, KY, NH, NV, MD and the countries of Australia, Switzerland, Germany, Denmark, Spain, Fin
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2778-2026
- MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Ongoing Class II Medical devices
- Recall started
- 27 May 2026
- Reason
- 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 diabetic ketoacidosis (DKA).
- Distribution
- International distribution to the countries of Spain, Great Britain, Netherlands, Italy.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2698-2026
- MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
Ongoing Class II Medical devices
- Recall started
- 13 February 2026
- Reason
- 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.
- Distribution
- Worldwide - US Nationwide distribution including in the states of OR, CA, AZ, NY,TX,FL, OH, MO, TN,NJ, NC, SC, IL, VA, WA, DC, GA, PA, MS,IA, MI, NH, OK, SD, MT, WI, WV, MA, LA, MN, RI, AR, ME, AL, IN, UT, KY, CO, ND, MD, CT, NM, KS, ID, NV, DE, NE, VT, AK, HI, WY, PR, VI and the countries of Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1745-2026, Z-1749-2026, Z-1752-2026, Z-1747-2026, Z-1748-2026, Z-1746-2026, Z-1750-2026, Z-1751-2026, Z-1741-2026, Z-1743-2026, Z-1740-2026, Z-1742-2026 and 2 more
- MiniMed 720G Insulin Pump (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
- Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
- Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
- MiniMed 620G Insulin Pump (MMT-1750)
- Paradigm Insulin Pump (MMT-712, MMT-715)
- MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
- Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
- MiniMed 530G Insulin Pump (MMT-551, MMT-751)
- and 6 more product lines
Ongoing Class II Medical devices
- Recall started
- 30 January 2026
- 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).
- Distribution
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1635-2026
- MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Ongoing Class II Medical devices
- Recall started
- 13 November 2025
- Reason
- 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 phone 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 insulin therapy, hyperglycemia.
- Distribution
- US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI, MD, PA, OK, KY, MA, DE, UT, ID, VA, MI, OH, LA, NJ, IA, MT, HI, AR, OR, SC, AL, CO, WY, VT, NV, GA, MS, SD, AK, WV, NH, ND, NM. OUS: Austria, Belgium, Chile, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0958-2026
- InPen App, Model/CFN Number: MMT-8061 (Android Users)
Ongoing Class II Medical devices
- Recall started
- 2 November 2025
- Reason
- 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.
- Distribution
- Worldwide - 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1238-2026
- 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
Ongoing Class II Medical devices
- Recall started
- 21 October 2025
- Reason
- 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.
- Distribution
- Worldwide Distribution: US (nationwide) including states of: TX, NC, MN, CA, VA, ID, WA, GA, MI, MA, OH, IL, IA, CT, FL, PA, NY, TN, AZ, LA, AL, NJ, CO, SC, MS, OR, MT, MD, KS, AK, NH, NE, WY, ND, IN, MO, WI, KY, UT, NV, SD, WV, NM, HI, AR, OK, VT, RI; and OUS (foreign) to countries of: Australia (A
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0594-2026
- CareLink Clinic, REF: MMT-7350
Ongoing Class II Medical devices
- Recall started
- 16 June 2025
- Reason
- 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 a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.
- Distribution
- International distribution to the countries of Argentina, Australia, Austria, Belgium, Bermuda, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2496-2025
- InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Ongoing Class II Medical devices
- Recall started
- 7 May 2025
- Reason
- The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.
- Distribution
- US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0033-2026
- Medtronic, Simplera Sensor, REF: MMT-5100JD1
Ongoing Class II Medical devices
- Recall started
- 4 March 2025
- Reason
- 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.
- Distribution
- US: OK, IA, NC, SC, MI, MN, CA, AZ, AL, MO, WA, IL, KS, TX, FL, MT, MD, OH, VA, NY, TN, HI, MA, NJ, PA, CO, WI, GA, CT, NE, OR, LA, NM, SD, ND, IN, NV, WV, RI, AR, NH
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1650-2025
- InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Ongoing Class II Medical devices
- Recall started
- 31 January 2025
- Reason
- 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 mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
- Distribution
- Worldwide - US 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, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY and the countries of
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1265-2025, Z-1259-2025, Z-1263-2025, Z-1255-2025, Z-1258-2025, Z-1257-2025, Z-1260-2025, Z-1256-2025, Z-1261-2025, Z-1264-2025, Z-1262-2025, Z-1266-2025
- MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
- MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
- MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
- Paradigm REF: MMT-712 and MMT-715
- MiniMed insulin pump, REF: 620G (MMT-1750)
- Paradigm insulin pump, REF: MMT-754
- MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
- Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
- and 4 more product lines
Ongoing Class I Medical devices
- Recall started
- 31 July 2024
- Reason
- 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 defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.
- Distribution
- US: CT, MI, PA, WA, IA, NY, ND, AZ, TX, OH, NC, AL, MN, IN, NJ, KY, UT, CA, FL, VA, MS, NM, NV, TN, GA, MA, NH, OK, VT, IL, ME, SC, LA, WY, RI, SD, KS, WI, MD, CO, DE, AR, AK, ID, MO, NE, WV, MT, OR, DC, HI, VI, PR. OUS: Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0002-2025, Z-0003-2025, Z-0001-2025
- MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MM
- MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MM
- 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
Ongoing Class II Medical devices
- Recall started
- 15 November 2023
- Reason
- 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 of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.
- Distribution
- Worldwide - US Nationwide distribution including in the states of PR, AK, AL, AR, AZ, CA, CO, CT, FL, GA, 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, WA, WI, WV, WY and the countries of Austria, Belgium, Cana
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1005-2024
- 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
Ongoing Class II Medical devices
- Recall started
- 21 November 2022
- Reason
- 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.
- Distribution
- OUS: Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Kazakhstan, Kuwait, Luxembourg, Moldova, Republic of, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbi
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0776-2023
- Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Ongoing Class II Medical devices
- Recall started
- 20 September 2022
- Reason
- 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 slowed or stopped, which could lead to hypoglycemia or hyperglycemia. The Remote Bolus feature on insulin pumps should be turned off to prevent the unauthorized access.
- Distribution
- US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. OUS: Andorra, Australia, Austria, Barbados, Belgium, Bermuda, Bolivia, Botswana
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0194-2023, Z-0193-2023
- Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
- 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
Ongoing Class II Medical devices
- Recall started
- 23 May 2022
- Reason
- 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.
- Distribution
- U.S.: 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, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY O.U.S.: Not provided
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1354-2022, Z-1357-2022, Z-1355-2022, Z-1356-2022, Z-1359-2022, Z-1358-2022, Z-1352-2022, Z-1353-2022
- MiniMed 640G Insulin Pump (O.U.S. Version)
- MiniMed 740G Insulin Pump (O.U.S. Version)
- MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
- MiniMed 720G Insulin Pump (O.U.S. Version)
- MiniMed 780G Insulin Pump (O.U.S. Version)
- MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
- MiniMed 620G Insulin Pump (O.U.S. version)
- MiniMed 630G Insulin Pump (U.S. and Canada Version)
Ongoing Class II Medical devices
- Recall started
- 27 January 2022
- Reason
- 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 hyperglycemia, which may lead to diabetic ketoacidosis. Current device labeling does not clearly identify that these insulin pumps are capable of functioning with the default basal setting of 0.0 units/hr for all 24 hours and that no error message will appear if the default basal setting remains active. Furthermore, the labeling for the affected devices does not highlight that saving the basal settings requires multiple steps and failure to complete all steps will not save the new basal settings, nor that the steps required to set and save a basal profile and other parameters which are used as part of the bolus calculator function are different.
- Distribution
- US: OH, UT, IL, NY, FL, LA, NE, NV, CA, VA, TX, DE, KS, MS, MI, AL, OK, AZ, SC, IN, AR, PA, WV, MA, RI, NJ, CO, TN, KY, GA, WI, MN, NM, MD, IA, NC, WY, MO, WA, OR, CT, ND, ME, VT, ID, SD, AK, MT, NH, DC, HI, PR, VI OUS: Australia, Japan, Korea, New Zealand, Taiwan, Viet Nam
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0855-2022
- 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-18
Ongoing Class II Medical devices
- Recall started
- 15 March 2021
- Reason
- 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.
- Distribution
- U.S.(Clinical): AR, CA, CO, CT, FL, GA, ID, MI, MN, TN, TX, and WA O.U.S.: Austria, Bahrain, Belgium, Canary Islands, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Israel, Italy, Liechtenstein, Luxembourg, Malta, Martiniqu
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1772-2021, Z-1771-2021
- MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KFX 670G V6.3 SF MG CLIN FR;¿ PUMP MMT-1741KFX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KX
- 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 CL
Ongoing Class II Medical devices
- Recall started
- 27 June 2019
- Reason
- 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.
- Distribution
- US nationwide distribution including Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1594-2020, Z-1592-2020, Z-1586-2020, Z-1581-2020, Z-1587-2020, Z-1595-2020, Z-1583-2020, Z-1584-2020, Z-1585-2020, Z-1582-2020, Z-1588-2020, Z-1590-2020 and 4 more
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
- MiniMed Insulin Pump, model # MMT-508
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
- Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754
- MiniMed Paradigm 512 Insulin pump
- MiniMed Paradigm Insulin pump, model number MMT-712
- and 8 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.