iLet Bionic Pancreas, REF: BB1001
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | March 12, 2026 |
| Reported | May 06, 2026 |
| Recalling firm | Beta Bionics, Inc. |
| Country / region | United States CA |
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.
Affected products
- iLet Bionic Pancreas, REF: BB1001
Related recalls
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