Beta Bionics recalls iLet Bionic Pancreas software versions 1.4.2 and 1.4.3 due to potential delayed glucose readings causing unsafe insulin dosing. Affected users may experience severe high or low blood sugar levels.
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.
Beta Bionics is recalling specific software versions for their iLet Bionic Pancreas insulin pumps. The software issue can cause delayed glucose readings from Dexcom G7 sensors, which may lead to missing insulin corrections for high or low blood sugar levels. This risk could cause severe hyperglycemia or hypoglycemia.
The software versions 1.4.2 and 1.4.3 have a problem with Dexcom G7 glucose sensors. This causes delayed readings, so the pump may not adjust insulin for high or low blood sugar levels. Without timely corrections, users could experience severe hyperglycemia or hypoglycemia.
Users of Beta Bionics iLet Bionic Pancreas insulin pumps with software versions 1.4.2 or 1.4.3 are affected. People with diabetes who rely on continuous glucose monitoring are most at risk.
Check your iLet Bionic Pancreas insulin pump software version. Versions 1.4.2 and 1.4.3 are affected. The recall covers devices sold with these software versions.
Review your iLet Bionic Pancreas software version to see if it is 1.4.2 or 1.4.3.
Update to a newer software version if available through Beta Bionics support.
Software versions 1.4.2 and 1.4.3 of the iLet Bionic Pancreas are affected.
The pump may delay glucose readings from Dexcom G7 sensors, leading to missing insulin corrections for high or low blood sugar levels.
Yes, the issue could cause severe hyperglycemia with or without diabetic ketoacidosis (DKA) or severe hypoglycemia.
We’ve drafted a message you can send Beta Bionics to request your refund or repair — edit it as you like.
Subject: Recall Z-1996-2026 — Beta Bionics Beta Bionics Hello, I own a Beta Bionics that is covered by recall Z-1996-2026 from Beta Bionics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
