Beta Bionics, Inc.: iLet Bionic Pancreas, REF: BB1001
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Beta Bionics, Inc.
- Product
- iLet Bionic Pancreas, REF: BB1001
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.
- Recall initiated
- 2026-03-12
- Code info
- Software versions 1.4.3, and 1.4.2
- Product quantity
- 1,080
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Irvine
- State
- CA
- Country
- United States
- Event id
- 98475
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