iLet Bionic Pancreas Insulin Only (REF BB1003)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9,393 adverse event reports that list this exact device (DI 00850050080190), received between Dec 4, 2025 and Sep 30, 2026 — classified as 2 deaths, 1,544 injuries, 7,847 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3,422 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 9,393 reports, 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, 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, 2026Intermittent Communication Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953505 ↗
• 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, 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 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  Patient problems: Dizziness; Hypoglycemia

  MAUDE report 50952063 ↗
• MalfunctionSep 30, 2026Fracture

  It was reported that the iLet pump touchscreen was cracked when the device, placed in a box during a move, collided with other items, resulting in a fractured touchscreen and an unusable screen on the pump. 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 stress-related problem associated with a fractured touchscreen component. It was concluded, based on previously established findings for similar reports, that the cause was traced to user handling.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952052 ↗
• MalfunctionSep 30, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952010 ↗
• MalfunctionSep 30, 2026Obstruction of Flow

  Patient problems: Hyperglycemia

  MAUDE report 50950053 ↗
• MalfunctionSep 30, 2026Leak/Splash

  It was reported that the user experienced leaking cartridges during a supply change, with insulin leaking inside the iLet during the press and hold step and filling the cartridge chamber, consistent with a device leak/splash associated with the reservoir component. No clinical signs, symptoms, or conditions reported. 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 leakage consistent with a seal issue, aligning with a leak/splash event 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949964 ↗
• MalfunctionSep 30, 2026Improper or Incorrect Procedure or Method

  Patient problems: Hyperglycemia

  MAUDE report 50949192 ↗
• InjurySep 30, 2026Improper or Incorrect Procedure or Method

  It was reported that the user¿s Dexcom G7 expired and the user applied a Dexcom G6 continuous glucose monitor (CGM) that was paired to the phone but not to the iLet, resulting in an extended time without CGM data on the pump and subsequent hyperglycemia; the user later entered the pairing code and successfully paired the G6 to the iLet after education on the pairing process and expected pairing time. Symptoms included hyperglycemia with a peak glucose of 502 mg/dL and associated polydipsia. Outcomes included a delay to treatment or therapy during the absence of CGM data. Investigation included communication with the user and analysis of information provided by the user. Investigation of this case revealed no device problem and identified a usage problem, specifically an improper or incorrect procedure in not following pairing instructions; no device component was applicable. It was concluded, based on previously established findings for similar reports, that the cause was failure to follow instructions and an unintended use error that contributed to the event.

  Patient problems: Hyperglycemia; Polydipsia

  MAUDE report 50948275 ↗
• MalfunctionSep 30, 2026Insufficient Device Problem Information

  Patient problems: Hyperglycemia

  MAUDE report 50946451 ↗
• MalfunctionSep 30, 2026Obstruction of Flow

  It was reported that the user experienced repeated occlusion alerts while using the infusion set and associated disposables, with alerts recurring despite multiple full supply changes and no observed bent cannulas, kinked tubing, or air bubbles; at one point the user disconnected and administered manual injections, then later resumed pump delivery after priming the tubing per troubleshooting. Symptoms included an interruption of insulin delivery consistent with an occlusion event without medical intervention. Outcomes included temporary reliance on manual injections with subsequent restoration of pump delivery after troubleshooting and supply changes, without hospitalization reported. Investigation included guided troubleshooting and education, including disconnection, tubing fill, and resumption of insulin delivery. Investigation of this case revealed an occlusion consistent with flow restriction in the disposable pathway, unresolved until supply change and line priming, with no confirmed hardware malfunction noted. It was concluded, based on previously established findings for similar reports, that the cause was user technique and disposable-related flow obstruction.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50945935 ↗
• InjurySep 30, 2026Insufficient Device Problem Information

  It was reported that the patient experienced hypoglycemia with a lowest CGM reading of 60 following a period of hyperglycemia, felt lightheaded and confused/disoriented, and treated the low with two glasses of orange juice per healthcare provider guidance; the patient uses a G7 CGM and expressed confusion regarding pump use and differing instructions, and the cause of the event was unclear. Symptoms included hypoglycemia, confusion/disorientation, and dizziness. Outcomes included an unexpected medical intervention in the form of oral glucose and the event was characterized as a serious injury/illness/impairment. Investigation included communication/interviews and analysis of information provided by the user. Investigation of this case revealed no findings available, with insufficient information for a device problem or component determination. 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: Confusion/ Disorientation; Dizziness; Hypoglycemia

  MAUDE report 50942416 ↗
• MalfunctionSep 30, 2026Insufficient Device Problem Information

  It was reported that a user of the iLet with Dexcom G7 experienced a high continuous glucose reading up to 195 mg/dL for about one hour while using a cartridge-driven infusion set on the stomach; the user attributed the rise to drinking coffee, had no symptoms, lacked a glucometer confirmation, and was trending down by the end of the call. Symptoms included hyperglycemia. Outcomes included no health consequences or impact. Investigation included communication with the user and analysis of information provided. Investigation of this case revealed no findings available, with insufficient information regarding a device problem or 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 50941846 ↗
• MalfunctionSep 30, 2026Insufficient Device Problem Information

  Patient problems: Hyperglycemia; Malaise

  MAUDE report 50941544 ↗
• MalfunctionSep 30, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941533 ↗
• MalfunctionSep 29, 2026Intermittent Communication Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940799 ↗
• InjurySep 29, 2026Improper or Incorrect Procedure or Method

  Patient problems: Hyperglycemia

  MAUDE report 50939168 ↗