iLet Bionic Pancreas Insulin Only (REF BB1004)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,822 adverse event reports that list this exact device (DI 00850050080206), received between Dec 4, 2025 and Sep 30, 2026 — classified as 1 death, 290 injuries, 1,531 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (657 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,822 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Intermittent Communication Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952259 ↗
• InjurySep 30, 2026Use of Device Problem

  It was reported that the patient experienced a low blood glucose event while sleeping, with a lowest value of 50 mg/dL, and was using the iLet pump; the patient received rapid-acting carbohydrates by mouth administered by another person after an urgent low alert and a rapid drop following prior pump-driven corrections and a subsequent pump pause and resume. Symptoms included hypoglycemia, loss of consciousness, sleepiness, confusion, irritability, lethargy, and vomiting. Outcomes included unexpected medication intervention and a serious injury or illness. Investigation included communication and interviews with the patient and analysis of information provided by the user or third party. The iLet Bionic Pancreas System User Guide (IFU) was reviewed as part of the investigation. Section 4.5.3 of the IFU was found to include instructions and/or warnings relevant to the reported event. No deficiencies in the IFU that would have contributed to the complaint were identified. Investigation of this case revealed no findings available and insufficient information regarding a specific medical device problem or component. It was concluded, based on previously established findings for similar

  Patient problems: Confusion/ Disorientation; Hypoglycemia; Irritability; Lethargy; Loss of consciousness; Sleepiness/Drowsiness/Somnolence; Vomiting

  MAUDE report 50952086 ↗
• InjurySep 30, 2026Improper or Incorrect Procedure or Method

  Patient problems: Dry Mouth; Fatigue; Hyperglycemia; Sleepiness/Drowsiness/Somnolence; Urinary Frequency / Polyuria

  MAUDE report 50952068 ↗
• MalfunctionSep 30, 2026Fracture

  It was reported that the patient¿s iLet would not unlock after the screen was cracked when the device was dropped, and the touchscreen in the bottom¿right corner was no longer usable; the device had been synced prior to shutdown, and the patient transitioned to backup therapy. Symptoms included no clinical signs, symptoms, or conditions. Outcomes included no health consequences or impact. Investigation included communication with the user and analysis of information provided by the user. Investigation of this case revealed a fracture-related stress problem of the touchscreen that prevented unlocking and normal operation. It was concluded, based on previously established findings for similar reports, that the cause was traced to the user.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952023 ↗
• MalfunctionSep 30, 2026Improper or Incorrect Procedure or Method

  Patient problems: Hyperglycemia

  MAUDE report 50949186 ↗
• MalfunctionSep 30, 2026Improper or Incorrect Procedure or Method

  Patient problems: Hyperglycemia; Muscle Weakness/Atrophy; Polydipsia

  MAUDE report 50949180 ↗
• MalfunctionSep 30, 2026Insufficient Device Problem Information

  It was reported that a user experienced hyperglycemia while using an iLet pump, with blood glucose rising above 300 mg/dL after a recent supply change and trending down following a full supply replacement; the user reported no device alarms, no infusion set or cartridge issues, and no non-iLet factors other than acute stress, and the medical device problem and device component details were not fully characterized due to insufficient information. Symptoms included hyperglycemia. Outcomes included no health consequences or impact. Investigation included interviews and analysis of information provided by the user or third party. Investigation of this case revealed no findings available, with insufficient information regarding a device problem or specific component involvement. It was concluded, based on previously established findings for similar reports, that the cause was not established. If the device is returned, a physical evaluation will be performed, and a supplemental will be submitted.

  Patient problems: Hyperglycemia

  MAUDE report 50941667 ↗
• MalfunctionSep 30, 2026Fracture

  It was reported that the iLet pump¿s touchscreen was cracked and became unresponsive after being carried in a pocket while working on ladders, with the exact mechanism unknown; the device continued basal delivery and automated corrections, though the user could not unlock the screen to announce meals, consistent with a device fracture involving the touchscreen component. Symptoms included no clinical signs, symptoms, or conditions. Outcomes included no health consequences or impact. Investigation included communication with the user and analysis of the information provided. Investigation of this case revealed a stress-related problem consistent with fracture of the touchscreen component. It was concluded, based on previously established findings for similar reports, that the cause was traced to user.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941640 ↗
• MalfunctionSep 30, 2026Key or Button Unresponsive/not Working

  It was reported that an iLet user experienced a nonresponsive sleep/wake button, with the screen only waking when the device was placed on a charger; after a guided restart via the iLet App, the button became responsive with haptic feedback and normal screen activation. Symptoms included no clinical effects. Outcomes included no impact to health and no alarms. Investigation included remote troubleshooting and user education. Investigation of this case revealed that the issue was resolved by a device restart, indicating transient user interface unresponsiveness of the sleep/wake control without ongoing device malfunction. It was concluded, based on previously established findings for similar reports, that the cause was a transient software or user interface anomaly resolved through restart.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941623 ↗
• MalfunctionSep 30, 2026Display Difficult to Read

  It was reported that the user had difficulty seeing and working with the iLet¿s black¿and¿white display, consistent with a display difficult to read issue related to the touchscreen, and the device was replaced with a unit featuring a color screen. Symptoms included no clinical signs, symptoms, or conditions. Outcomes included no health consequences or impact. Investigation included communication with the user and analysis of information provided by the user and care team. Investigation of this case revealed an ambient light problem affecting display visibility, aligning with a display readability issue involving the touchscreen. It was concluded, based on previously established findings for similar reports, that the cause was traced to component failure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941603 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hot Flashes/Flushes; Hypoglycemia

  MAUDE report 50941549 ↗
• MalfunctionSep 30, 2026Insufficient Device Problem Information

  Patient problems: Hyperglycemia

  MAUDE report 50941548 ↗
• MalfunctionSep 29, 2026Intermittent Communication Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941039 ↗
• MalfunctionSep 29, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940169 ↗
• MalfunctionSep 29, 2026Improper or Incorrect Procedure or Method

  It was reported that a patient experienced a blood glucose reading of 204 mg/dL after the iLet pump lost power due to a depleted battery, which stopped insulin delivery until the pump was recharged and restarted. Symptoms included no reported clinical symptoms. Outcomes included no medical intervention or hospitalization. Investigation included troubleshooting and education regarding power management and confirmation that insulin delivery resumes when the device is powered and reconnected. The iLet Bionic Pancreas System User Guide (IFU) was reviewed as part of the investigation. Section 4.3.1 of the IFU was found to include instructions and/or warnings relevant to the reported event. No deficiencies in the IFU that would have contributed to the complaint were identified. Investigation of this case revealed user-related interruption of therapy because the patient did not use alternative insulin therapy after the pump shut off, with contributing factors of low and very low battery. It was concluded, based on previously established findings for similar reports, that the cause was user-related therapy interruption due to inadequate charging practices.

  Patient problems: Hyperglycemia

  MAUDE report 50938684 ↗
• MalfunctionSep 29, 2026Obstruction of Flow

  It was reported that the patient experienced persistent hyperglycemia while using iLet with FL3 CGM and an inset infusion set on the abdomen, including a CGM value near 400 mg/dL and subsequent fingerstick values up to 564 mg/dL, with an occlusion alert initially and a bent cannula (reported on a separate case) observed upon site removal that resolved after a full supply change; later, another supply change was performed, and glucose eventually trended to 180 mg/dL. No adverse clinical symptoms associated with hyperglycemia reported. Outcomes included no health consequences or impact. Investigation included communication with the patient and analysis of information provided by the user. Investigation of this case revealed no device problem found, with lack of effect due to insulin delivery interruption consistent with an infusion set issue and insufficient information regarding a specific device component. It was concluded, based on previously established findings for similar reports, that the cause was not established.

  Patient problems: Hyperglycemia

  MAUDE report 50935876 ↗
• MalfunctionSep 29, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926887 ↗
• MalfunctionSep 29, 2026Display Difficult to Read

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926734 ↗
• MalfunctionSep 28, 2026Failure to Infuse

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926688 ↗
• MalfunctionSep 28, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926340 ↗
• MalfunctionSep 28, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925311 ↗
• MalfunctionSep 28, 2026Improper or Incorrect Procedure or Method

  Patient problems: Hyperglycemia

  MAUDE report 50924033 ↗
• MalfunctionSep 28, 2026Computer Software Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922864 ↗
• MalfunctionSep 28, 2026Computer Software Problem

  It was reported that the iLet displayed Alert 57 and the user restarted the iLet; the user also had backup therapy available and was using a Dexcom G7 sensor, which aligns with a computer software problem related to the device¿s computer software component. Symptoms included no clinical signs, symptoms, or conditions. Outcomes included no health consequences or impact. Investigation included communication with the user, analysis of information provided by the user or third party, and an event history log review. Investigation of this case revealed a software runtime error consistent with a computer software problem in the computer software component. It was concluded, based on previously established findings for similar reports, that the cause was traced to software coding. If the device is returned, a physical evaluation will be performed, and a supplemental will be submitted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922700 ↗
• MalfunctionSep 28, 2026Computer Software Problem

  It was reported that the iLet displayed alert code 57 and the user restarted the device, which cleared the alarm; this aligns with a computer software problem involving the computer software component. Symptoms included no clinical signs, symptoms, or conditions. Outcomes included no health consequences or impact. Investigation included communication and interviews, analysis of information provided by the user, and an event history log review. Investigation of this case revealed a software runtime error consistent with a computer software problem within the computer software component. It was concluded, based on previously established findings for similar reports, that the cause was traced to software coding. If the device is returned, a physical evaluation will be performed, and a supplemental will be submitted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922438 ↗