Bigfoot Unity Diabetes Management System ASM-10027Recalls & reported problems

Bigfoot Biomedical, Inc. · Bigfoot Unity Cap for Humalog-Lispro-Lyumjev · Class 2

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

Adverse event reports: 13
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00850003506111), received between Jul 24, 2025 and Jul 25, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (13 reports).

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.

Reports received per month

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

Most reported problems

Device problems

Application Program Freezes or Fails to Launch13

Patient problems

No Clinical Signs, Symptoms or Conditions13

Recent adverse event reports

The 13 most recent of 13 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 22618292 ↗
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 22612890 ↗
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 22610716 ↗
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 22610578 ↗
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 22610108 ↗
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 22606788 ↗
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 22606726 ↗
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 22606478 ↗
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 22606429 ↗
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 22593174 ↗
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 22592643 ↗
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 22592582 ↗
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 22588447 ↗

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

Device details

UDI-DI	`00850003506111`
Brand	Bigfoot Unity Diabetes Management System
Model	ASM-10027
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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FreeStyle Libre 3 App 72075-01
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Bigfoot Unity Diabetes Management System ASM-10046
Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
1 recall12 reports
Bigfoot Unity Diabetes Management System FG-300173
Bigfoot Biomedical, Inc. · Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
1 recall0 reports

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

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
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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