Bigfoot Unity Diabetes Management System FG-300186Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00850003506234), received between Aug 1, 2023 and Aug 1, 2023 — classified as 2 injuries.

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT THEY HAD EXPERIENCED A SEVERE HYPOGLYCEMIC EVENT DURING THE PREVIOUS TWO WEEKS. NO FURTHER INFORMATION WAS PROVIDED. MULTIPLE ATTEMPTS TO COLLECT ADDITIONAL INFORMATION WERE UNSUCCESSFUL.

  Patient problems: Hypoglycemia

  MAUDE report 17438516 ↗
• InjuryAug 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED THAT THEY WERE HOSPITALIZED WITH BG LEVELS OF 1500 MG/DL. PATIENT REPORTED THAT THEIR LONG-ACTING INSULIN WAS CHANGED RECENTLY FROM NOVOLIN-N (USING VIAL/SYRINGE) TO TOUJEO (USING INSULIN PEN), AND THEY JUST STARTED USING BIGFOOT UNITY SYSTEM.

  Patient problems: Hyperglycemia

  MAUDE report 17436431 ↗

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