Guardian 4 SensorRecalls & reported problems across all models

We found 2 models of Guardian 4 Sensor by Medtronic Minimed, Inc. in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Guardian 4 Sensor recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 15, 2023Open, Classified

   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.

   Z-1005-2024 · Root cause: Process change control · names 2 of these models · Recall details · FDA record ↗

Guardian 4 Sensor models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Guardian™ 4 Sensor MMT-7040A

  Sensor, Glucose, Invasive, Component of automated insulin delivery system
  1 recall0 reports
• Guardian™ 4 Sensor MMT-7040MA

  Sensor, Glucose, Invasive, Component of automated insulin delivery system
  1 recall0 reports

Other Medtronic Minimed, Inc. products

• MiniMed 670G23 models · 141,169 reports · 4 recalls
• MiniMed 630G23 models · 65,972 reports · 6 recalls
• Paradigm REAL-Time Revel180 models · 49,838 reports · 2 recalls
• MiniMed 530G71 models · 48,745 reports · 1 recall
• MiniMed670G2 models · 28,871 reports · 3 recalls
• MiniMed630G2 models · 6,656 reports · 5 recalls
• MiniMed Reservoir6 models · 4,545 reports
• PARADIGM REAL-time95 models · 2,862 reports · 1 recall