Bigfoot Unity Diabetes Management System FG-300206Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850003506401), received between Feb 22, 2022 and Nov 9, 2023 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED SYMPTOMS OF HYPOGLYCEMIA INCLUDING DIS-ORIENTATION AND TIREDNESS ON (B)(6) 2022. THE CUSTOMER DID NOT TREAT THEIR HYPOGLYCEMIC EVENT. THE CUSTOMER STATED THAT THEY RECEIVED LOW GLUCOSE ALERTS FROM THE BIGFOOT UNITY SYSTEM. THERE WAS NO REPORT OF THE CUSTOMER REQUIRING THIRD PARTY ASSISTANCE OR MEDICAL INTERVENTION.

  Patient problems: Confusion/ Disorientation; Fatigue; Hypoglycemia

  MAUDE report 18104220 ↗
• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER EXPERIENCED SYMPTOMS OF SEVERE HYPOGLYCEMIA INCLUDING LIGHTHEADEDNESS AND INCOHERENCE. THE CUSTOMER REQUIRED ASSISTANCE FROM THEIR SPOUSE WHO PROVIDED SOME CARBOHYDRATES (PEANUT BUTTER CRACKERS AND MILK) TO TREAT THE LOW GLUCOSE CONDITION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT.

  Patient problems: Aphonia; Dizziness; Hypoglycemia

  MAUDE report 14309699 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT EXPERIENCED SYMPTOMS OF SEVERE HYPOGLYCEMIA FOR ABOUT AN HOUR, INCLUDING DISORIENTATION AND MEMORY LAPSE FOR SOME OF THE TIME. CUSTOMER WAS UNABLE TO SELF-TREAT, REQUIRING TREATMENT WITH GLUCOSE TABLETS AND ORANGE JUICE PROVIDED BY THEIR SON. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THE EVENT.

  Patient problems: Confusion/ Disorientation; Hypoglycemia

  MAUDE report 13582051 ↗

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