Bigfoot Unity Diabetes Management System ASM-10046Recalls & reported problems

Bigfoot Biomedical, Inc. · Bigfoot Unity Cap for Novolog-Aspart · Class 2

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 12
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00850003506173), received between Jul 23, 2025 and Jul 25, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (12 reports).

1 FDA recall record name this device's 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, 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

May 21, 2025Class IIOpen, Classified
Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people living with diabetes as they may not have all information necessary to make a timely treatment decision.
Z-1997-2025 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Device problems

Application Program Freezes or Fails to Launch12

Patient problems

No Clinical Signs, Symptoms or Conditions12

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 25, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22615983 ↗
MalfunctionJul 25, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22615914 ↗
MalfunctionJul 25, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22613161 ↗
MalfunctionJul 25, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22612227 ↗
MalfunctionJul 25, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22610115 ↗
MalfunctionJul 25, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22606795 ↗
MalfunctionJul 25, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22606677 ↗
MalfunctionJul 25, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22606378 ↗
MalfunctionJul 24, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22600739 ↗
MalfunctionJul 24, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22594165 ↗
MalfunctionJul 24, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22591332 ↗
MalfunctionJul 23, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
A CUSTOMER REPORTED RECEIVING DEVICE ERROR FROM A BIGFOOT UNITY DEVICE. THIS IS A KNOWN ISSUE FOR THE SERIAL NUMBER ASSOCIATED WITH THIS COMPLAINT, ADDRESSED BY THE FIELD ACTION FA-001 (FDA RECALL 3016525500/05162025/C). THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22583834 ↗

Device details

UDI-DI	`00850003506173`
Brand	Bigfoot Unity Diabetes Management System
Model	ASM-10046
Company	Bigfoot Biomedical, Inc.
Product code	QLG · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Class	Class 2
FDA submission	K202145
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jul 14, 2025

Device type (GMDN): Percutaneous interstitial fluid glucose monitoring system, electrochemical

An assembly of electrically-powered, portable devices intended to continuously monitor interstitial fluid glucose concentrations in a patient with diabetes mellitus, using an invasive electrochemical technique. It consists of an electrochemical, percutaneously-inserted electrode that physically connects to a cable or transmitter which communicates with a monitor or receiver (not included) that captures, stores, and converts the sensor signals to glucose concentrations for display. The system may be used in the home and clinical settings, and aids in the detection of episodes of hyperglycaemia and hypoglycaemia, facilitating acute/long-term therapy adjustments.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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