Severity
Moderate
FDA Devices recall · Reported June 9, 2021
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…
Medtronic Minimed recalled MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 … - a moderate-severity action.
MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL;¿ PUMP MMT-1886 … was recalled by Medtronic Minimed in June 9, 2021. Reason: Due to a software design issue, under certain conditions, a software fault is detected when a large bolus del…. Check the official notice for the remedy. Verify recall #Z-1771-2021 with the FDA Devices before acting.
The recall
Medtronic Minimed issued this moderate-severity FDA Devices recall-Due to a software design issue, under certain conditions, a software fault is detected when a large bolus del….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1771-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1771-2021) was formally reported on June 9, 2021, with the manufacturer initiating the action on March 15, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medtronic Minimed is listed as the recalling firm, operating out of Northridge, CA. Federal records list the affected scope as O.U.S. Distibution only = 15,682 devices.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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, Hung…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,409 medical devices recalls on record
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
O.U.S. Distibution only = 15,682 devices
Related Recalls
6
6 from same agency
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;¿ KIT MMT-1896WWA MM780G BLE MG TR;¿ KIT MMT-1896WWA MM780G BLE MG NL;¿ KIT MMT-1896WWA MM780G BLE MG FR;¿ KIT MMT-1896WWA MM780G BLE MG ES;
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1771-2021 |
| Date reported | June 9, 2021 |
| Date initiated | March 15, 2021 |
| Recalling firm | Medtronic Minimed |
| Firm location | Northridge, CA |
| Affected scope | O.U.S. Distibution only = 15,682 devices |
| 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, Irelan… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
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This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported June 9, 2021.
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.