Device recall: MiniMed 780G Insulin Pump: Models: PUMP MMT-1885 MM780G 6.5V BLE MMOL; PUMP MMT-1886 MM780G 6.5W BLE MG; KIT…
Class II FDA enforcement event 87735. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
The recalling firm started this device recall on 15 Mar 2021. The FDA record names a person as the firm, and this site does not show the name. The firm address in the FDA record is in Northridge, CA. FDA put the recall in Class II. FDA event 87735 has 2 product records. The first FDA enforcement report date is 9 Jun 2021. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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,…
Recalling firm
The name is withheld, Northridge, CA.
The FDA record gives the name of a person as the recalling firm. This site does not show the names of persons.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1771-2021 | 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… | O.U.S. Distibution only = 15,682 devices | Class II | Ongoing | 9 Jun 2021 |
| Z-1772-2021 | 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 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… | U.S. Investigational Clinical Study = 1,266 devices | Class II | Ongoing | 9 Jun 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 2
Official channels
- FDA enforcement report Z-1771-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 87735. https://recallregister.com/fda/ii/87735/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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,…
- What quantity of product is in FDA event 87735?
- The event has 2 product records. The first record gives this quantity:
O.U.S. Distibution only = 15,682 devices
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.