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Bigfoot Unity Diabetes Management System FG-300205Recalls & reported problems

Bigfoot Biomedical, Inc. · Bigfoot Unity Diabetes Management System for Novolog-Aspart and Toujeo Max Only · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850003506395), received between Aug 23, 2022 and Aug 23, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K202145); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Patient problems

  • Hypoglycemia1
  • Loss of consciousness1
  • Tachycardia1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

Recalls under the same FDA submission

These recalls involve devices cleared under K202145. One submission often covers many models, so check the product and lot details in each record.

  • Z-1997-2025 · May 21, 2025 · Open, Classified
    Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmwar

Other Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems devices

All Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page