Beta Bionics, Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
iLet Bionic Pancreas, REF: BB1001
Software versions 1.4.3, and 1.4.2
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →