iLet Bionic PancreasRecalls & reported problems across all models
Beta Bionics, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16,934
- Deaths reported
- 8
- Injuries reported
- 2,728
- Recalls
- 0
We found 4 models of iLet Bionic Pancreas by Beta Bionics, Inc. in the FDA's device registry (GUDID). Together they are named in 16,934 adverse event reports in the FDA's MAUDE database, received between Apr 8, 2025 and Sep 30, 2026 — classified as 8 deaths, 2,728 injuries, 14,198 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5,700 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported iLet Bionic Pancreas problems
Device problems
- Insufficient Device Problem Information5,700
- Improper or Incorrect Procedure or Method2,404
- Fracture1,870
- Intermittent Communication Failure1,393
- Key or Button Unresponsive/not Working1,108
- Failure to Infuse905
- Charging Problem420
- Obstruction of Flow420
Patient problems
- No Clinical Signs, Symptoms or Conditions7,298
- Hyperglycemia7,052
- Hypoglycemia3,536
- Insufficient Information368
- Dizziness244
- Shaking/Tremors235
- Headache230
- Nausea229
iLet Bionic Pancreas models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- iLet Bionic Pancreas Insulin OnlyInteroperable Automated Glycemic Controller2 deaths9,393 reports
- iLet Bionic Pancreas Insulin OnlyInteroperable Automated Glycemic Controller5 deaths5,718 reports
- iLet Bionic Pancreas Insulin OnlyInteroperable Automated Glycemic Controller1 death1,822 reports
- iLet Bionic Pancreas Insulin OnlyInteroperable Automated Glycemic Controller1 report
Recent iLet Bionic Pancreas adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Insufficient Device Problem Information
Patient problems: Hyperglycemia
MAUDE report 50954908 ↗InjurySep 30, 2026Obstruction of Flow
Patient problems: Hyperglycemia
MAUDE report 50954783 ↗MalfunctionSep 30, 2026Fitting Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954701 ↗MalfunctionSep 30, 2026Improper or Incorrect Procedure or Method
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954513 ↗MalfunctionSep 30, 2026Improper or Incorrect Procedure or Method
Patient problems: Hyperglycemia
MAUDE report 50954147 ↗MalfunctionSep 30, 2026Insufficient Device Problem Information
Patient problems: Hyperglycemia
MAUDE report 50953824 ↗MalfunctionSep 30, 2026Insufficient Device Problem Information
Patient problems: Hyperglycemia
MAUDE report 50953762 ↗MalfunctionSep 30, 2026Intermittent Communication Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953505 ↗MalfunctionSep 30, 2026Improper or Incorrect Procedure or Method
Patient problems: Hyperglycemia
MAUDE report 50953494 ↗MalfunctionSep 30, 2026Intermittent Communication Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953436 ↗MalfunctionSep 30, 2026Obstruction of Flow
Patient problems: Hyperglycemia
MAUDE report 50953412 ↗MalfunctionSep 30, 2026Intermittent Communication Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952259 ↗MalfunctionSep 30, 2026Unexpected Shutdown
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952214 ↗MalfunctionSep 30, 2026Premature Discharge of Battery
It was reported that an iLet insulin pump experienced rapid battery depletion after charging to full, with the battery dropping by roughly one-third during a meal announcement and repeating over multiple days, consistent with a premature battery discharge involving the battery component. Symptoms included hyperglycemia with a highest reported blood glucose of 400 mg/dL. Outcomes included a missed dose and a delay to therapy. Investigation included interviews and analysis of information provided by the user and engineering logs. Investigation of this case revealed an energy storage system problem consistent with premature discharge of the battery component. It was concluded, based on previously established findings for similar reports, that the cause was traced to component failure.
Patient problems: Hyperglycemia
MAUDE report 50952207 ↗MalfunctionSep 30, 2026Intermittent Communication Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952106 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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