Omnipod 5 Controller PDM-H001-G-XXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2,116 adverse event reports that list this exact device (DI 10385083000022), received between Jun 19, 2022 and Sep 30, 2026 — classified as 14 deaths, 1,001 injuries, 1,101 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (470 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 2,116 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Battery Problem

  Patient problems: Dyspnea; Hyperglycemia; Polydipsia

  MAUDE report 50947880 ↗
• MalfunctionSep 30, 2026Fire; Melted; Overheating of Device; Smoking; Battery Problem

  It was reported by the patient that the Omnipod 5 Controller/Personal Diabetes Manager (PDM) was charging overnight when they smelled smoke and the PDM "caught on fire," however the patient denied any flames being present. The patient stated that the PDM was smoking, smoldering and the charging port had melted. The controller remained functional until the battery was depleted; however, due to the damaged charging port, it could no longer be recharged. The patient was uncertain whether an Insulet-provided charging cable and adapter were being used at the time of the event. The patient stated that the cord they were using was black and there were no prior damages. No harm to the patient was reported and no medical assistance was required. A replacement PDM and charger was issued to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947466 ↗
• MalfunctionSep 30, 2026Overheating of Device; Battery Problem

  It was reported that the patient¿s Omnipod 5 controller/Personal Diabetes Manager (PDM) becomes warm to the touch when charging and loses charge faster than expected. It was reported that the heated area appears to be where the battery is located in the device. No harm to the patient was reported and no medical assistance was required. A replacement controller and charging cable have been issued to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947462 ↗
• MalfunctionSep 30, 2026Delayed Program or Algorithm Execution

  It was reported that when a bolus was commanded on the Omnipod Dash Controller/ Personal Diabetes Manager (PDM) it would not deliver until hours later, resulting in the patient receiving a sudden rush of insulin. The patient¿s blood glucose levels were approximately 20 mmol/L (360 mg/dL) when they administered the bolus. When the bolus didn¿t initially deliver, the patient administered manual injections, but this had caused ¿dangerous lows¿ when the bolus delivered later. No medical assistance was required.

  Patient problems: Hyperglycemia

  MAUDE report 50946569 ↗
• MalfunctionSep 30, 2026Failure to Deliver

  It was reported that the Omnipod 5 Controller/ Personal Diabetes Manager (PDM) was not delivering complete boluses commanded by the patient. The patient reported administering a bolus of 10 units of insulin, but the PDM delivered approximately 5 units of insulin over a two-hour period. The patient¿s blood glucose level was reported to be elevated due to this issue, with a level of 250 mg/dL being specifically reported. No medical assistance was required.

  Patient problems: Hyperglycemia

  MAUDE report 50942931 ↗
• MalfunctionSep 29, 2026Failure to Deliver

  Patient problems: Hyperglycemia

  MAUDE report 50936480 ↗
• MalfunctionSep 29, 2026Failure to Deliver

  The patient's parent reported that the patient attempted to administer meal boluses by entering carbohydrate and blood glucose values into the Omnipod app; however, the bolus treatments did not appear in the activity history. The parent stated that insulin did not appear to be delivered, resulting in elevated post-meal blood glucose levels. No error messages were displayed during the reported events. Blood glucose values were not reported. No medical attention was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935493 ↗
• InjurySep 29, 2026Insufficient Device Problem Information

  It was reported that the patient had been hospitalized with Diabetic Ketoacidosis (DKA) on February 1, 2026. The patient's blood glucose reached 600 mg/dL while wearing the Pod between 24 and 36 hours. Symptoms reported include stomach pain and sugar not going down. The patient was treated with insulin (long acting and fast acting) for 12 hours. The patient was discharged after 12 hours.

  Patient problems: Abdominal Cramps; Hyperglycemia

  MAUDE report 50933736 ↗
• MalfunctionSep 29, 2026Overheating of Device; Battery Problem

  It was reported by the patient that the Omnipod 5 Controller/Personal Diabetes Manager (PDM) will no longer hold a charge, became excessively hot and while charging; there was melting and bulging near the charging port. The patient also reported that the controller was struggling to stay connected to their Dexcom G7 and was slowly losing charge. The patient stated that they were using a black charging cord. No harm to the patient was reported and no medical assistance was required. A replacement PDM was issued to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932074 ↗
• MalfunctionSep 29, 2026Unintended System Motion

  It was reported that the patients Omnipod 5 Controller/Personal Diabetes Manager (PDM) had administered an uncommanded bolus ((b)(4) and that "multiple people" in her Facebook support group mentioned this had happened to them too. (b)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931470 ↗
• MalfunctionSep 29, 2026Overheating of Device; Battery Problem

  It was reported that the patient¿s Omnipod 5 controller/Personal Diabetes Manager (PDM) is not holding charge and overheating during use. The patient reported they had experienced several instances of hypoglycaemia (no values provided), no medical assistance was required. A replacement controller has been issued to the patient.

  Patient problems: Hypoglycemia

  MAUDE report 50929945 ↗
• InjurySep 28, 2026Problem with Software Installation

  Patient problems: Hyperglycemia

  MAUDE report 50917709 ↗
• MalfunctionSep 28, 2026Leak/Splash

  It was reported that the Omnipod 5 controller/Personal Diabetes Manager (PDM)'s battery was leaking and the patient hypothesised that the battery was corroded. No harm to the patient was reported and no medical assistance was required. A replacement PDM was issued to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913726 ↗
• InjurySep 28, 2026Unintended System Motion

  It was reported the Omni pod 5 Controller/ Personal Diabetes Manager (PDM) delivered two uncommand boluses. The first was 10 units delivered on (b)(6) 2026 (Insulet reference number (b)(4) did not require medical assistance) and the second was 15 units on (b)(6)2026 (Insulet reference number (b)(4). The second uncommanded bolus resulted in the patient experiencing hypoglycemia and requiring EMS to administer intravenous Dextrose. The patient blood glucose level had declined to 21 mg/dL. It was reported that the PDM was next to the patient at the time of the event, on the arm of their chair.

  Patient problems: Cognitive Changes; Hypoglycemia

  MAUDE report 50911707 ↗
• DeathSep 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by a patient¿s ex-husband that the patient had passed away due to Diabetic Ketoacidosis (DKA) and it was requested to close their Insulet account. Further information obtained via the patient¿s online obituary on (b)(6) 2026 confirmed that the patient had passed away on (b)(6) 2026. There were no reported issues with the Omnipod 5 system. It was reported that an inquest into the patient¿s death is scheduled for an unspecified date in (b)(6) 2026. No further information was provided. Insulet is in contact with the initial reporter. If additional information is received, Insulet will submit a supplemental report.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 50799622 ↗
• MalfunctionSep 8, 2026Fire; Smoking

  The patient reported that the controller was connected to a charger and, within approximately 5 to 10 minutes of charging, the controller began emitting smoke and caught fire. No adverse event or medical attention was reported. Blood glucose values were not reported. The patient will be issued a new device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676225 ↗
• MalfunctionSep 8, 2026Thermal Decomposition of Device; Fire

  The patient reported that the OmniPod 5 touchscreen controller appeared to burn while charging. The patient observed visible burn damage to the charging port, including black residue inside the port, melting on the bottom of the controller, and burning of the serial number label. The patient stated that the controller had been charging for approximately 25 minutes when it became extremely hot and began producing steam/smoke. Following the event, the controller remained partially functional; however, the touchscreen became overly sensitive, and the device would no longer charge properly. The Insulet-supplied charging cable was also reported to have sustained damage, with melting observed at the connection point. The damaged charging cable was discarded by the patient. The pod in use on the patient's arm was unaffected by the incident. The patient reported having a backup method of diabetes management available. Blood glucose levels were not reported. Medical attention was not required. The patient will be issued a new device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675562 ↗
• MalfunctionSep 2, 2026Failure to Deliver

  Patient problems: Hyperglycemia

  MAUDE report 50569066 ↗
• MalfunctionSep 1, 2026Failure to Deliver

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548006 ↗
• DeathAug 28, 2026Insufficient Device Problem Information

  It was reported by a MCN Manager in diabetes/specialist dietitian on (b)(6) 2026 that the patient had passed away and it was requested to close their Insulet account. Further information received from the healthcare professional on (b)(6) 2026 following a follow-up request from Insulet reported that the patient was using the Omnipod 5 system at the time of their passing. The cause of death was reported as not known and the date of death was not reported. The patient was not hospitalised at the time of their death. There were no reported issues with the Omnipod 5 system and no change in the patient's blood glucose levels was reported. The location of the Pod worn during the event and the controller are currently unknown to Insulet. No further information was provided. An attempt to obtain additional information was made 24 August 2026; no information has been received thus far. If additional information is received, a supplemental report will be submitted.

  Patient problems: Insufficient Information

  MAUDE report 50497512 ↗
• MalfunctionAug 28, 2026Thermal Decomposition of Device; Battery Problem

  It was reported that the Omnipod 5 controller/Personal Diabetes Manager (PDM) charging port and cable melted after the cable was forcibly pulled on. The PDM would not hold charge following this and the patient's blood glucose level read as "HIGH" overnight. No medical assistance was required. A replacement PDM and charging cable were issued to the patient.

  Patient problems: Hyperglycemia

  MAUDE report 50496037 ↗
• MalfunctionAug 25, 2026Thermal Decomposition of Device; Battery Problem

  The patient reported that after connecting a discharged controller to a charger, the device was left charging for approximately 35 minutes before an alarm was heard. Upon inspection, the charging cable had reportedly overheated and fused to the controller's charging port, leaving the controller unable to charge and displaying a battery level of 1%. The patient stated that a non-Insulet USB charging cable was being used because the original Insulet-supplied charging cable was lost. Medical attention was not required. The patient will be issued a new device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436859 ↗
• InjuryAug 24, 2026Insufficient Device Problem Information

  It was reported by the Health Care Provider that the patient had been hospitalized with Diabetic Ketoacidosis (DKA) sometime in July. A specific date and length of stay was not provided. No blood glucose levels were provided. Treatment details were not provided. It was reported that the patient's controller died and they were without insulin. Three follow up attempts have been made with no further information available.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 50421330 ↗
• InjuryAug 24, 2026Problem with Software Installation

  It was reported that the patient was hospitalized with high blood glucose (BG) in (b)(6) 2026. The patient's blood glucose levels reached 1130 mg/dL. The patient stated that she wasn't able to get into her account in the Omnipod 5 Controller because she had to hard reset it because the device had an issue where it was stuck on App Initialization " LOADING SCREEN" at step 19 /29 and then started again while trying to turn it on but was able to get in the Log in screen after a hard reset. She said as a result, she was not receiving the Insulin she needed since the Omnipod 5 Controller wasn't working. The patient diagnosis was that she had high blood glucose levels because she was unable to receive her insulin at the time. The patient was treated with 15 units of insulin. The patient was discharged after a half a day on (b)(6) 2026.

  Patient problems: Hyperglycemia

  MAUDE report 50419267 ↗
• InjuryAug 24, 2026Insufficient Device Problem Information

  It was reported that the patient presented to the emergency room with hyperglycemia on (b)(6) 2026. The patient's blood glucose level rose to above 300 mg/dL while wearing the Pod for an unknown duration. The patient reported that the Pod failed to deliver insulin for more than two hours while operating in Automated Mode. The patient administered multiple correction boluses; however, elevated blood glucose levels persisted. The system reportedly entered Automated Limited Mode and continued delivering zero microboluses despite the elevated blood glucose levels. Symptoms reported include nausea, weakness, dehydration, fatigue, malaise, and the presence of ketones. No additional information regarding medical treatment or patient outcomes was provided.

  Patient problems: Dehydration; Fatigue; Hyperglycemia; Malaise; Nausea

  MAUDE report 50418719 ↗