Diabetes Management System Firmware Issue May Disable Insulin Pen Functionality
Bigfoot Unity Diabetes Management System pen caps may become unresponsive due to firmware issues, preventing insulin delivery. The FDA Class II recall affects 57 units.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall affecting a critical diabetes management system where the device may become unresponsive, preventing insulin delivery and patient decision-making. No reported illnesses or injuries to date, making this a risk-of-harm product without realized harm, consistent with High severity.
Plain-English summary
Bigfoot Biomedical is recalling 57 Bigfoot Unity Diabetes Management System pen caps due to a firmware issue in Firmware 1.3.0 Release Configuration. The pen caps—available in both Rapid-Acting (RCAP) and Long-Acting (LCAP) versions—integrate continuous glucose monitoring with automated insulin dose recommendations for diabetes management.
The firmware issue may cause the device to display an error and become unresponsive, preventing the insulin pen from functioning properly. When the device is unresponsive, patients cannot administer insulin and lack critical information to make timely treatment decisions, creating a potential health risk for people living with diabetes.
The affected pen caps were distributed across nine U.S. states: Alabama, Florida, Georgia, Iowa, Illinois, New York, Pennsylvania, Texas, and Washington. Users who believe they have an affected device should consult their healthcare provider or contact Bigfoot Biomedical for instructions on device replacement or alternative treatment options.
The recalled product
- Product
- 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 Firmware 1.3.0 Release Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the
- Manufacturer
- BIGFOOT BIOMEDICAL
- Hazard
- firmware-defect
- device-malfunction
- insulin-delivery-failure
Distribution
Distributed nationwide across the United States.
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