Medtronic MiniMed: 33 FDA recall reports
Every medical device recall the FDA has published for Medtronic MiniMed. The fault, and how the agency graded it.
33Reports
1Class I
30Ongoing
2023-01-11Most recent
1 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
Z-0776-2023 · Class II · reported 2023-01-11 · Ongoing
- Why it was recalled
- 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.
- Product
- Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
- Where it went
- 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, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom
- How much
- 3235
Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
Z-0194-2023 · Class II · reported 2022-11-16 · Ongoing
- Why it was recalled
- 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.
- Product
- Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712, MMT-1751, MMT-1752
- Where it went
- 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, Canada, Canary Islands, Cayman Islands, Chile, Czech Republic, Denmark, Dominican Rep., El Salvador, Faroe Islands, Finland, France, Germany, Gibraltar, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Kenya, Liechtenstein, Luxembourg, Mauritius, Mexico, Namibia, Netherlands, New Zealand, Norway, Paraguay, Peru, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Trinidad and Tobago, Turkey, Uganda, United Kingdom, Venezuela
- How much
- 316326
Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 670G/ MMT-1780, MMT-1781, MMT-1782,
Z-0193-2023 · Class II · reported 2022-11-16 · Ongoing
- Why it was recalled
- 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.
- Product
- 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
- Where it went
- 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, Canada, Canary Islands, Cayman Islands, Chile, Czech Republic, Denmark, Dominican Rep., El Salvador, Faroe Islands, Finland, France, Germany, Gibraltar, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Kenya, Liechtenstein, Luxembourg, Mauritius, Mexico, Namibia, Netherlands, New Zealand, Norway, Paraguay, Peru, Poland, Portugal, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Trinidad and Tobago, Turkey, Uganda, United Kingdom, Venezuela
- How much
- 399651
MiniMed 640G Insulin Pump (O.U.S. Version)
Z-1354-2022 · Class II · reported 2022-07-20 · Ongoing
- Why it was recalled
- 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.
- Product
- MiniMed 640G Insulin Pump (O.U.S. Version)
- Where it went
- 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
- How much
- 323,417 pumps
MiniMed 740G Insulin Pump (O.U.S. Version)
Z-1357-2022 · Class II · reported 2022-07-20 · Ongoing
- Why it was recalled
- 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.
- Product
- MiniMed 740G Insulin Pump (O.U.S. Version)
- Where it went
- 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
- How much
- 40 pumps
MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
Z-1355-2022 · Class II · reported 2022-07-20 · Ongoing
- Why it was recalled
- 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.
- Product
- MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
- Where it went
- 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
- How much
- 279,251 pumps
MiniMed 720G Insulin Pump (O.U.S. Version)
Z-1356-2022 · Class II · reported 2022-07-20 · Ongoing
- Why it was recalled
- 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.
- Product
- MiniMed 720G Insulin Pump (O.U.S. Version)
- Where it went
- 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
- How much
- 575 pumps
MiniMed 780G Insulin Pump (O.U.S. Version)
Z-1359-2022 · Class II · reported 2022-07-20 · Ongoing
- Why it was recalled
- 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.
- Product
- MiniMed 780G Insulin Pump (O.U.S. Version)
- Where it went
- 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
- How much
- 83,398 pumps
MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
Z-1358-2022 · Class II · reported 2022-07-20 · Ongoing
- Why it was recalled
- 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.
- Product
- MiniMed 770G Insulin Pump (U.S. and O.U.S. Version)
- Where it went
- 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
- How much
- 123,585 pumps
MiniMed 620G Insulin Pump (O.U.S. version)
Z-1352-2022 · Class II · reported 2022-07-20 · Ongoing
- Why it was recalled
- 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.
- Product
- MiniMed 620G Insulin Pump (O.U.S. version)
- Where it went
- 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
- How much
- 2,287 pumps
MiniMed 630G Insulin Pump (U.S. and Canada Version)
Z-1353-2022 · Class II · reported 2022-07-20 · Ongoing
- Why it was recalled
- 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.
- Product
- MiniMed 630G Insulin Pump (U.S. and Canada Version)
- Where it went
- 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
- How much
- 126,558 pumps
MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, M
Z-0855-2022 · Class II · reported 2022-04-06 · Ongoing
- Why it was recalled
- 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.
- Product
- 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; MiniMed 620G (OUS Only): MMT-1750; MiniMed 640G (OUS Only): MMT-1711, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G (OUS Only): MMT-1809, MMT-1810, MMT-1859, MMT-1860; MiniMed 740G (OUS Only): MMT-1811, MMT-1812, MMT-1861, MMT-1862; MiniMed 780G (OUS Only): MMT-1884, MMT-1885, MMT-1886, MMT-1895, MMT-1896 The MiniMed" 630G System with SmartGuard is intended for continuous delivery of basal insulin (at user selected rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons sixteen years of age and older.
- Where it went
- 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
- How much
- 175,801
MiniMed 670G Insulin Pump: Models: PUMP MMT-1740KX 670G V6.3 SF MG CLIN;¿ PUMP MMT-1740KX 670G V6.3 CLIN 02
Z-1772-2021 · Class II · reported 2021-06-09 · Ongoing
- Why it was recalled
- 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.
- Product
- 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 670G V6.3 SF MG CLIN GER;¿ PUMP MMT-1741KX 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1741KXS 670G V6.3 SF MG CLIN IS;¿ PUMP MMT-1741KXS 670G V6.3 CLIN 020 MG;¿ PUMP MMT-1742KX 670G V6.1 MM CLIN;¿ PUMP MMT-1742KX 670G V6.3 SF MM CLIN;¿ PUMP MMT-1742KX 670G V6.3 SF MM CLIN SLO;¿ PUMP MMT-1742KX 670G V6.3 CLIN 020 MM;¿ PUMP MMT-1742KX 670G V6.3 CLIN 020 EU MM;¿
- Where it went
- 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, Martinique, Netherlands, New Caledonia, Norway, Poland, Qatar, Reunion, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, and United Kingdom
- How much
- U.S. Investigational Clinical Study = 1,266 devices
MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG;
Z-1771-2021 · Class II · reported 2021-06-09 · Ongoing
- Why it was recalled
- 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.
- Product
- 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;¿ PUMP MMT-1885XC 780G V6.5 CLIN MM;¿ PUMP MMT-1886XC 780G V6.5 CLIN MG;¿ PUMP MMT-1885L MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886L MM780G 6.5W BLE MG;¿ KIT MMT-1896ES MM780G V6.5W MG;¿ KIT MMT-1896WWA MM780G BLE MG ES;¿ KIT MMT-1895WWA MM780G BLE MMOL AR;¿ KIT MMT-1895WWA MM780G BLE MMOL CS;¿ KIT MMT-1895WWA MM780G BLE MMOL DA;¿ KIT MMT-1895WWA MM780G BLE MMOL DE;¿ KIT MMT-1895WWA MM780G BLE MMOL EN;¿ KIT MMT-1895WWA MM780G BLE MMOL FI;¿ KIT MMT-1895WWA MM780G BLE MMOL FR;¿ KIT MMT-1895WWA MM780G BLE MMOL IT;¿ KIT MMT-1895WWA MM780G BLE MMOL NL;¿ KIT MMT-1895WWA MM780G BLE MMOL NO;¿ KIT MMT-1895WWA MM780G BLE MMOL SL; KIT MMT-1895WWA MM780G BLE MMOL SV;¿ KIT MMT-1895WWA MM780G BLE MMOL HU;¿ KIT MMT-1896WWA MM780G BLE MG AR;¿ KIT MMT-1896WWA MM780G BLE MG DE;¿ KIT MMT-1896WWA MM780G BLE MG EL;¿ KIT MMT-1896WWA MM780G BLE MG HE;¿ KIT MMT-1896WWA MM780G BLE MG IT;¿ KIT MMT-1896WWA MM780G BLE MG PL;¿ KIT MMT-1896WWA MM780G BLE MG RO;¿ ...
- Where it went
- 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, Martinique, Netherlands, New Caledonia, Norway, Poland, Qatar, Reunion, Romania, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, and United Kingdom
- How much
- O.U.S. Distibution only = 15,682 devices
Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
Z-1594-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 72,850
Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
Z-1592-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 27
Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
Z-1586-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 73,028
MiniMed Insulin Pump, model # MMT-508
Z-1581-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- MiniMed Insulin Pump, model # MMT-508
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 64,174 units
Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
Z-1587-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 88,243
Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754
Z-1595-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 68,598
MiniMed Paradigm 512 Insulin pump
Z-1583-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- MiniMed Paradigm 512 Insulin pump
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 34,777
MiniMed Paradigm Insulin pump, model number MMT-712
Z-1584-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- MiniMed Paradigm Insulin pump, model number MMT-712
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 74,496
Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
Z-1585-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 36,143
MiniMed Paradigm Model 511 Insulin Pump
Z-1582-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- MiniMed Paradigm Model 511 Insulin Pump
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 30,479
Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
Z-1588-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 225,498
Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
Z-1590-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 17
Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT-754CM
Z-1596-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT-754CM
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 2,322
Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
Z-1589-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 38
Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
Z-1593-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 10
Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
Z-1591-2020 · Class II · reported 2020-04-01 · Ongoing
- Why it was recalled
- 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.
- Product
- Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
- Where it went
- US nationwide distribution including Puerto Rico.
- How much
- 23,221
Showing the 30 most recent of 33. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls