iLet Bionic Pancreas Insulin Only (REF BB1002)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,718 adverse event reports that list this exact device (DI 00850050080183), received between Dec 4, 2025 and Sep 30, 2026 — classified as 5 deaths, 893 injuries, 4,820 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1,621 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 5,718 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fitting Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954701 ↗
• 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, 2026Improper or Incorrect Procedure or Method

  Patient problems: Hyperglycemia

  MAUDE report 50953494 ↗
• MalfunctionSep 30, 2026Premature Discharge of Battery

  It was reported that an iLet displayed a persistent ¿Charge iLet Now¿ message and failed to charge despite extended time on the charging pad, repositioning, use of alternate outlets, and removal of the case clip, resulting in battery depletion and interruption of insulin delivery; the patient¿s CGM showed a highest glucose of 327 mg/dL during approximately 10 hours without insulin, and the device was not connected to the infusion set during this period, consistent with a device battery problem involving the battery component. Symptoms included hyperglycemia. Outcomes included no health consequences or impact. Investigation included interviews and analysis of information provided by the user. Investigation of this case revealed an energy storage system problem consistent with premature battery discharge associated with the battery component. It was concluded, based on previously established findings for similar reports, that the cause was traced to component failure. The patient planned to contact a healthcare provider for backup therapy.

  Patient problems: Hyperglycemia

  MAUDE report 50952059 ↗
• MalfunctionSep 30, 2026Premature Discharge of Battery

  It was reported that the user contacted support about perceived decreased battery longevity on an approximately three¿year¿old iLet pump, raising concern for premature battery discharge involving the battery 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 information provided by the user, including review of battery logs. Investigation of this case revealed that the battery component was operating within normal capacity, and no device problem was found despite the initial concern for premature battery discharge. It was concluded, based on previously established findings for similar reports, that no problem was detected.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951947 ↗
• MalfunctionSep 30, 2026Charging Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951020 ↗
• MalfunctionSep 30, 2026Intermittent Communication Failure

  It was reported that the iLet displayed a ¿Calibration Not Used¿ alert while paired with a Dexcom G7, with concurrent signal loss and the sensor initially not paired; restarting the iLet was advised and the sensor successfully paired shortly thereafter, indicating an intermittent communication failure potentially related to the antenna component within the electrical and magnetic subsystem. 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 an interoperability problem between systems consistent with intermittent communication failure, with involvement of the antenna component. It was concluded, based on previously established findings for similar reports, that the cause was traced to a component failure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950978 ↗
• MalfunctionSep 30, 2026Intermittent Communication Failure

  It was reported that the iLet displayed an alert to connect the CGM or enter a BG with dosing set to stop in several hours after the user started a new Dexcom G7 sensor, and no CGM readings appeared on the iLet or phone until the user unlocked the iLet following troubleshooting that included restarting the iLet, toggling between G6 and G7 sensor types, and re-pairing with the G7 using pairing code 8653; the problem aligns with intermittent communication failure involving the electrical and magnetic subsystem, specifically the antenna, in the context of Dexcom G7 interoperability. 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 an interoperability problem identified between the iLet and the Dexcom G7 manifesting as intermittent communication failure attributable to the antenna component. 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 50950647 ↗
• InjurySep 30, 2026Improper or Incorrect Procedure or Method

  Patient problems: Hyperglycemia; Nausea

  MAUDE report 50949213 ↗
• MalfunctionSep 30, 2026Insufficient Device Problem Information

  It was reported that a user contacted support regarding an inability to change target range on the iLet while also noting an insulin set expired alert on a Dexcom G7 system, with the user indicating recent supply changes and concern that a setting adjustment was made; the device problem and component could not be determined due to insufficient information. Symptoms included hyperglycemia with a reported CGM value of 300 mg/dL. Outcomes included hyperglycemia only, with no additional impacts reported. Investigation included communication with the user and analysis of information provided by the user. Investigation of this case revealed no findings and insufficient information to establish a device-related problem or a specific component involved. 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 50946708 ↗
• InjurySep 30, 2026Leak/Splash

  It was reported that the iLet pump¿s cartridge chamber was leaking during setup, prompting the user to switch to subcutaneous insulin via pens and experience hyperglycemia up to 400 mg/dL, with the issue associated to a leak/splash in the reservoir component. Symptoms included elevated ketones, headache, thirst, fatigue, and muscle weakness consistent with hyperglycemia. Outcomes included missed insulin doses, an unexpected need for medication, a delay to therapy, and characterization as a serious illness. Investigation included communication with the user, analysis of information provided by the user, a dry run on the pump, and guidance to perform a full supply change using new supplies. Investigation of this case revealed leakage at or related to a seal, consistent with a medical device leak/splash involving the reservoir component. It was concluded, based on previously established findings for similar reports, that the cause was traced to component failure.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Fatigue; Headache; Hyperglycemia; Muscle Weakness/Atrophy; Polydipsia

  MAUDE report 50946561 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  It was reported that the user experienced hypoglycemia while the iLet pump was paused, with CGM readings as low as 50 mg/dL and a concurrent fingerstick of 76 mg/dL, and remote review confirmed a recorded pause, no insulin delivery during the low event aside from a small dose earlier, and a data gap likely related to charging; the agent advised rechecking every 15 minutes and explained that insulin suspension occurs at the target threshold and that individual physiology can allow continued BG decline despite suspension. Symptoms included hypoglycemia without reported physical symptoms. Outcomes included self-treatment with four glucose tablets and a snack and continued home monitoring without hospitalization. Investigation included remote data review through the app and verification of pump pause status and delivery history, along with offer to escalate for internal software review. Investigation of this case revealed no evidence of insulin delivery during the event and no device alarms, consistent with expected suspend behavior, with the low glucose attributed to physiological factors rather than device malfunction. It was concluded, based on previously established findings for si

  Patient problems: Hypoglycemia

  MAUDE report 50946519 ↗
• MalfunctionSep 30, 2026Failure to Infuse

  It was reported that during a supply change an Alert 38 motor stall occurred and persisted after a restart, preventing supply changes or dry runs, consistent with a device failure to infuse associated with the motor 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 information provided by the user or third party. Investigation of this case revealed a communications problem identified in relation to a failure to infuse involving the motor component. It was concluded, based on previously established findings for similar reports, that the cause was traced to component failure. 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 50941604 ↗
• MalfunctionSep 29, 2026Intermittent Communication Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940903 ↗
• MalfunctionSep 29, 2026Improper or Incorrect Procedure or Method

  Patient problems: Hyperglycemia

  MAUDE report 50938913 ↗
• MalfunctionSep 29, 2026Obstruction of Flow

  Patient problems: Hyperglycemia

  MAUDE report 50938710 ↗
• MalfunctionSep 29, 2026Intermittent Communication Failure

  It was reported that the user received a Pairing Failed alert when attempting to pair a Dexcom G7 continuous glucose monitor (CGM) to the iLet, despite entering the correct pairing code, and after guidance to toggle settings and re-enter pairing code, the device successfully paired and began displaying glucose values, consistent with an intermittent communication failure involving the antenna component. No adverse clinical symptoms reported. Outcomes included no health consequences or impact. Investigation included communication with the user and analysis of the information the user provided. Investigation of this case revealed an interoperability problem between the CGM and the iLet consistent with intermittent communication failure, with involvement of the electrical and magnetic subsystem, including the antenna component. 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 50938302 ↗
• MalfunctionSep 29, 2026Fitting Problem

  It was reported that during a supply change the iLet pump prompted for new infusion set insertion, but the infusion set connector would insert without being able to twist to lock, preventing attachment; after two unsuccessful connectors, a third connector attached successfully and drops were confirmed, indicating a fitting problem involving the connector/coupler. No clinical signs, symptoms, or conditions reported. Outcomes included no health consequences or impact. Investigation included communication with the user and analysis of the information provided by the user. Investigation of this case revealed a mechanical problem involving the connector/coupler consistent with a fitting problem. 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 50936063 ↗
• MalfunctionSep 29, 2026Obstruction of Flow

  It was reported that the patient experienced multiple occlusion alerts with Inset 23" infusion sets connected to an iLet, occurring predominantly 1¿6 hours after site changes, often during the night and after meal announcements, with only 20¿40% of meal insulin delivered and proper priming steps and connections confirmed. Symptoms included hyperglycemia with continuous glucose monitor (CGM) high and blood glucose of 400 mg/dL, accompanied by thirst. Outcomes included interruption of insulin delivery requiring repeated supply and site changes, and continued alerts until replacement supplies from a different lot were used. Investigation included remote troubleshooting, a pump dry run confirming adequate pump motor performance, and user education on full supply changes and monitoring. Investigation of this case revealed no visible kinks, clogs, or blood in the cannula or tubing, drops seen during initial fill, correct connections, potential contribution from scar tissue at the upper buttocks site and pump worn below the site, and a lot-specific pattern reported by the user, indicating infusion set occlusion related to the infusion set and/or site rather than the pump. It was concluded

  Patient problems: Hyperglycemia

  MAUDE report 50934732 ↗
• MalfunctionSep 29, 2026Key or Button Unresponsive/not Working

  It was reported that the iLet pump¿s screen became unresponsive to touch upon waking, and review of a user-provided video supported that the device was not functioning properly, consistent with a touchscreen component problem. 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 or a third party. Investigation of this case revealed a software-related issue associated with a touchscreen component, consistent with an unresponsive key or button type malfunction. It was concluded, based on previously established findings for similar reports, that the cause was traced to a component failure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930257 ↗
• MalfunctionSep 29, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926928 ↗
• MalfunctionSep 29, 2026Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926914 ↗
• MalfunctionSep 29, 2026Moisture Damage

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926894 ↗
• MalfunctionSep 29, 2026Key or Button Unresponsive/not Working

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926888 ↗