Medtronic Minimed recalls
Medtronic Minimed appears in 85 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- MiniMed 780G Insulin Pump (O.U.S. Version)
FDA Device · Class II · 2022-07-20 · Medtronic Minimed
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. - MiniMed 630G Insulin Pump (U.S. and Canada Version)
FDA Device · Class II · 2022-07-20 · Medtronic Minimed
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. - MiniMed 670G Insulin Pump (U.S. and O.U.S. Version)
FDA Device · Class II · 2022-07-20 · Medtronic Minimed
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. - MiniMed 630G: MMT-1715, MMT-1754, MMT-1755
FDA Device · Class II · 2022-04-06 · Medtronic Minimed
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 n… - 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.…
FDA Device · Class II · 2021-06-09 · Medtronic Minimed
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… - MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 MM780G 6.5W BLE MG
FDA Device · Class II · 2021-06-09 · Medtronic Minimed
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… - Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - MiniMed Paradigm Model 511 Insulin Pump
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - MiniMed Paradigm Insulin pump, model number MMT-712
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - MiniMed Paradigm 512 Insulin pump
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554 and MMT-754
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - MiniMed Insulin Pump, model # MMT-508
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - Medtronic MiniMed Paradigm Veo Insulin pump, model numbers MMT-554CM and MMT-754CM
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
FDA Device · Class II · 2020-04-01 · Medtronic Minimed
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 pote… - CareLink iPro2 Reports, Model No. MMT-7340 is software intended to retrospectively calibrates sensor data and provides reports of continuou…
FDA Device · Class II · 2016-04-27 · Medtronic Minimed
Reason: 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 senso… - MiniMed 620G, 3.0mL mg/dL, Model No. MMT-1710 The MiniMed 620G and MiniMed 640G insulin pump systems are indicated for the continuous deliv…
FDA Device · Class II · 2015-12-23 · Medtronic Minimed
Reason: 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 greasin… - MiniMed 640G, 3.0mL mmol/L, 3.0mL mg/dL, Model No. MMT-1711 and MMT-1712 The MiniMed 620G and MiniMed 640G insulin pump systems are indicat…
FDA Device · Class II · 2015-12-23 · Medtronic Minimed
Reason: 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 greasin… - Guardian Real-Time Monitor, Model No. CSS7100
FDA Device · Class II · 2015-09-02 · Medtronic Minimed
Reason: 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 translati… - MiniMed NGP 640G 1.8ml (mmol/L), Model No. MMT-1511
FDA Device · Class II · 2015-08-05 · Medtronic Minimed
Reason: 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 lo… - CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider managemen…
FDA Device · Class III · 2015-03-11 · Medtronic Minimed
Reason: 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 pu… - Medtronic MiniMed Silhouette and/or MiniMed Sure-T Infusion Sets
FDA Device · Class II · 2014-12-17 · Medtronic Minimed
Reason: 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 ca… - Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522…
FDA Device · Class II · 2014-09-03 · Medtronic Minimed
Reason: 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. - Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian RE…
FDA Device · Class II · 2014-08-20 · Medtronic Minimed
Reason: 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. - Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
FDA Device · Class II · 2014-08-20 · Medtronic Minimed
Reason: 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 t… - 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 ins…
FDA Device · Class II · 2013-08-28 · Medtronic Minimed
Reason: 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 t… - Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps
FDA Device · Class I · 2013-07-17 · Medtronic Minimed
Reason: 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 con… - Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K,…
FDA Device · Class II · 2013-04-17 · Medtronic Minimed
Reason: 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…