Omnipod DASH PDM PDM-USA1-D001-MG-USA1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,129 adverse event reports that list this exact device (DI 10385082000009), received between Dec 11, 2018 and Sep 30, 2026 — classified as 10 deaths, 343 injuries, 776 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (466 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Oct 17, 2022Class ITerminated

   The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM.

   Z-0154-2023 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,129 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Overheating of Device; Battery Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50955211 ↗
• MalfunctionSep 28, 2026Overheating of Device; Battery Problem

  It was reported by the patient that the Omnipod Dash Controller/Personal Diabetes Manager (PDM) that their newly replaced PDM is not holding a charge. The patient also reported that the PDM charger is overheating. 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 50915315 ↗
• MalfunctionAug 27, 2026Fire

  The patient stated that the controller charging cord showed brown discoloration at the ends, which the patient alleged to be indicative of signs of burning. Additionally, the patient reported that the device became hot during operation. No medical event was reported. The patient will be issued a new device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50479932 ↗
• MalfunctionAug 25, 2026Stretched; Explosion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50435429 ↗
• InjuryJul 7, 2026No Display/Image

  THE PATIENT DECLINED TO PROVIDE INCIDENT DETAILS BUT STATED THAT THE EVENT WAS SIMILAR TO AN OCCURRENCE FROM (B)(6) 2026. BASED ON INFORMATION FROM THE (B)(6) 2026 INCIDENT, THE PATIENT WENT TO THE EMERGENCY ROOM WITH HYPERGLYCEMIA. NO BLOOD GLUCOSE READINGS WERE REPORTED. THE PATIENT REPORTED THAT THE POD CONTROLLER HAD A UNRESPONSIVE, BLACK SCREEN, AND WAS MAKING CONTINUOUS BEEPING AND VIBRATING NOISES. THE PATIENT WAS TREATED WITH INSULIN VIA INTRAVENOUS THERAPY AND FLUIDS.

  Patient problems: Hyperglycemia

  MAUDE report 25736545 ↗
• MalfunctionJun 29, 2026Overheating of Device; Battery Problem

  IT WAS REPORTED THAT THE OMNIPOD DASH CONTROLLER/PERSONAL DIABETES MANAGER (PDM) HAD A POOR BATTERY LIFE AND WAS HOT TO TOUCH. 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 25649705 ↗
• MalfunctionJun 23, 2026Unintended Power Up; Overheating of Device; Battery Problem

  THE PATIENT REPORTED THAT HER OMNIPOD DASH PDM BECAME UNRESPONSIVE WHILE ATTEMPTING TO FILL A POD. THE DEVICE REMAINED STUCK ON THE ¿OMNIPOD DASH¿ LOADING SCREEN FOR OVER AN HOUR AND BECAME EXCESSIVELY HOT. SHE WAS UNABLE TO POWER IT OFF, EVEN AFTER REMOVING AND REINSERTING THE BATTERY. THE PDM WAS APPROXIMATELY TWO WEEKS OLD AND HAD SHOWN ISSUES SINCE INITIAL USE, INCLUDING UNEXPECTED DATE/TIME CHANGES, A SIX-HOUR DELAY BEFORE ALLOWING INSULIN DELIVERY, AND POOR BATTERY PERFORMANCE (HOLDING A CHARGE FOR ONLY 24¿30 HOURS). A REPLACEMENT OF THE PDM WAS PROCESSED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25594218 ↗
• InjuryJun 11, 2026No Display/Image; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM (ER) WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS EXCEEDED 600 MG/DL DUE TO LACK OF INSULIN DELIVERY. THE PATIENT REPORTED THAT THE POD CONTROLLER HAD A UNRESPONSIVE, BLACK SCREEN, AND WAS MAKING CONTINUOUS BEEPING AND VIBRATING NOISES. SYMPTOMS REPORTED INCLUDE THIRSTY, NAUSEA, AND DIZZINESS. THE PATIENT WAS TREATED WITH INSULIN VIA INTRAVENOUS (IV) THERAPY AND FLUIDS. THE PATIENT WAS DISCHARGED ONCE BLOOD SUGAR LEVELS DECREASED ON THE SAME DAY.

  Patient problems: Dizziness; Hyperglycemia; Nausea; Polydipsia

  MAUDE report 25480242 ↗
• MalfunctionJun 11, 2026Charging Problem; Excessive Heating

  THE PATIENT REPORTED THAT WHEN CHARGING THE OMNIPOD PERSONAL DIABETES MANAGER (PDM), THE BOTTOM OF THE DEVICE OVERHEATS AND THE PDM CHARGES SLOWLY. ADDITIONALLY, THE PATIENT REPORTED THAT THE DEVICE CHARGES TO 100% BUT DRAINS COMPLETELY OVERNIGHT. THE PATIENT'S BLOOD GLUCOSE LEVELS WERE CONSISTENTLY ELEVATED (CURRENT READING AT 320 MG/DL) OVER A 3¿4-DAY PERIOD. THE PATIENT STATED TO BE USING A GREEN CHARGER (DEXCOM-ISSUED).

  Patient problems: Hyperglycemia

  MAUDE report 25470658 ↗
• MalfunctionJun 5, 2026Application Program Problem: Medication Error

  IT WAS REPORTED BY THE LEGAL GUARDIAN (LG) THAT THE BASAL PRESETS OF THE PATIENT'S POD CONTROLLER WAS INACTIVE. THE LG NOTICED THIS WHEN THE PATIENT WOKE UP WITH ELEVATED BLOOD GLUCOSE (BG) LEVELS. NO IMPACT TO THE PATIENT'S GLUCOSE LEVELS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417477 ↗
• MalfunctionMay 22, 2026Leak/Splash

  IT WAS REPORTED THAT THE PATIENT'S CONTROLLER WAS MELTING AND THAT THE BATTERY WAS LEAKING. NO IMPACT TO BLOOD GLUCOSE LEVELS WAS REPORTED. MEDICAL TREATMENT WAS NOT REQUIRED. THE PATIENT WAS PROVIDED A REPLACEMENT CONTROLLER. THE PATIENT REPORTED THEY HAVE INSULIN INJECTION PENS TO USE, UNTIL THEIR NEW CONTROLLER ARRIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254247 ↗
• MalfunctionMay 21, 2026Program or Algorithm Execution Failure

  THE PATIENT REPORTED ISSUES WITH THEIR BASAL INSULIN PROGRAM. THE PATIENT STATED THAT THEIR BASAL INSULIN PRESET PROGRAMS WERE INACTIVE AND AS A RESULT THE PATIENT DID NOT RECEIVE INSULIN OVERNIGHT. THE PATIENT REPORTED THAT THEIR BLOOD GLUCOSE LEVELS WENT HIGH BUT DID NOT PROVIDE SPECIFIC VALUES. MEDICAL TREATMENT WAS NOT REQUIRED. PATIENT WAS PROVIDED A REPLACEMENT CONTROLLER.

  Patient problems: Hyperglycemia

  MAUDE report 25243648 ↗
• MalfunctionMay 15, 2026Overheating of Device

  PATIENT REPORTED THAT THE PDM GETS HOT AFTER BEING ON THE CHARGER FOR ABOUT 20 MINUTES. THE PATIENT WAS USING AN INSULET PROVIDED CHARGING CABLE. NO PATIENT INJURY WAS REPORTED, AND MEDICAL INTERVENTION WAS NOT REQUIRED. THE PATIENT WAS PROVIDED A REPLACEMENT CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182544 ↗
• MalfunctionMay 14, 2026Stretched

  PATIENT REPORTED THAT THE BATTERY OF THE CONTROLLER HAS FULLY EXPANDED FROM THE BACK SIDE, AND HE IS AFRAID OF PLUGGING THE DEVICE INTO A CHARGER, AS THEY FEEL THE BATTERY MIGHT EXPLODE. NO IMPACT TO BLOOD GLUCOSE LEVELS WERE REPORTED. MEDICAL TREATMENT WAS NOT REQUIRED. THE PATIENT WAS PROVIDED A REPLACEMENT CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25171420 ↗
• MalfunctionMay 13, 2026Overheating of Device

  IT WAS REPORTED THAT THE CHARGING CABLE GETS HOT WHENEVER THE CONTROLLER IS CHARGING. NO IMPACT TO THE PATIENT'S BLOOD GLUCOSE LEVELS WERE REPORTED. MEDICAL TREATMENT WAS NOT REQUIRED. THE PATIENT WAS PROVIDED A REPLACEMENT CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162974 ↗
• MalfunctionMay 11, 2026Overheating of Device

  IT WAS REPORTED THAT WHILE CHARGING, THE CONTROLLER AND CHARGER WERE OVERHEATING AND IT WOULD NOT TURN ON. NO IMPACT TO BLOOD GLUCOSE LEVELS WERE REPORTED. MEDICAL TREATMENT WAS NOT REQUIRED. THE PATIENT WAS SENT A REPLACEMENT CONTROLLER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137594 ↗
• InjuryMay 1, 2026Operating System Becomes Nonfunctional

  THE PATIENT REPORTED THAT HER GLUCOSE LEVELS INCREASED TO ABOVE 500 MG/DL AFTER THE DASH CONTROLLER DISPLAYED A BOOT/RECOVERY MODE SCREEN THAT THE PATIENT COULD NOT NAVIGATE AND SUBSEQUENTLY TURNED BLACK. MULTIPLE ATTEMPTS TO REBOOT THE CONTROLLER WERE UNSUCCESSFUL, INCLUDING BATTERY REMOVAL/REINSERTION AND CHARGING. THIS RESULTED IN OVERNIGHT HYPERGLYCEMIA. THE PATIENT REPORTED ADMINISTERING A MANUAL INSULIN INJECTION, WHICH RESULTED IN SEVERE HYPOGLYCEMIA, WITH BLOOD GLUCOSE DECREASING BELOW 2 MG/DL. SHE SUBSEQUENTLY LOST CONSCIOUSNESS AND WAS TRANSPORTED BY AMBULANCE TO THE EMERGENCY ROOM ON (B)(6) 2026, WHERE SHE REMAINED FOR APPROXIMATELY SEVEN HOURS. REPORTED DIAGNOSES INCLUDED HYPOGLYCEMIA, LOW BLOOD PRESSURE (BELOW 70), ATRIAL FIBRILLATION, AND HIGH RISK FOR STROKE OR HEART ATTACK; HOWEVER, NO STROKE OR HEART ATTACK WAS CONFIRMED. THE PATIENT WAS TREATED WITH INTRAVENOUS GLUCOSE AND INTRAVENOUS FLUIDS AND RETURNED HOME THE SAME DAY.

  Patient problems: Hyperglycemia; Hypoglycemia; Loss of consciousness

  MAUDE report 25058378 ↗
• MalfunctionApr 30, 2026Overheating of Device

  THE PATIENT REPORTED THAT THEIR CONTROLLER WAS OVERHEATING, WHILE CHARGING. PATIENT WAS USING AN INSULET SUPPLIED CHARGING CABLE. NO IMPACT TO BLOOD GLUCOSE LEVELS WAS REPORTED. MEDICAL TREATMENT WAS NOT REQUIRED. A REPLACMENT CONTROLLER WAS SENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044302 ↗
• MalfunctionApr 15, 2026Stretched

  IT WAS REPORTED THAT THE PERSONAL DIABETES MANAGER (PDM) BATTERY WAS EXPANDING. THE PATIENT REPORTED THE PDM HAD BEEN STILL WORKING AS EXPECTED AND THERE WAS NO IMPACT REPORTED TO THEIR BLOOD GLUCOSE LEVELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888142 ↗
• MalfunctionApr 9, 2026Failure to Deliver

  IT WAS REPORTED THAT A BOLUS COULD NOT BE DELIVERED ON THE PATIENT'S DASH CONTROLLER/PERSONAL DIABETES MANAGER (PDM). A MESSAGE APPEARED ON THE PDM THAT THE PATIENT COULD NOT RECALL, HOWEVER, THERE WERE NO AUDIBLE ALARMS GENERATED. NO HARM TO THE PATIENT WAS REPORTED AND NO MEDICAL ASSISTANCE WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829954 ↗
• MalfunctionApr 6, 2026Thermal Decomposition of Device; Display Difficult to Read; Overheating of Device

  IT WAS REPORTED THAT THE CONTROLLER OVERHEATED, MELTED AND THE SCREEN CRACKED AND THE COLOR OF THE SCREEN CHANGED, WHILE THE CONTROLLER WAS CHARGING. THE USER WAS SENT A REPLACEMENT DEVICE. PATIENT'S BLOOD GLUCOSE LEVELS WERE REPORTED TO BE GREATER THAN 250 MG/DL. NO PATIENT INJURY WAS REPORTED, AND MEDICAL INTERVENTION WAS NOT REQUIRED.

  Patient problems: Hyperglycemia

  MAUDE report 24789324 ↗
• MalfunctionMar 19, 2026Smoking

  IT WAS REPORTED BY THE PRESTATAIRE THAT THE PATIENT SAW SMOKE APPEARING AROUND THE CHARGING PORT AND CABLE WHILE THE OMNIPOD 5 CONTROLLER/PERSONAL DIABETES MANAGER WAS CHARGING. NO HARM TO THE PATIENT WAS REPORTED AND NO MEDICAL ASSISTANCE WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636744 ↗
• MalfunctionMar 18, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED THAT ON (B)(6) 2026 THE PATIENT'S BLOOD GLUCOSE DECREASED TO 40 MG/DL WHILE WEARING THE POD BETWEEN 4 AND 24 HOURS. THE PATIENT THOUGHT THE POD KEPT DELIVERING INSULIN EVEN WHEN SUSPENDED. WHEN THEY REMOVED THE POD, IT STILL HAD INSULIN SLOWLY COMING OUT OF THE CANNULA.

  Patient problems: Hypoglycemia

  MAUDE report 24629913 ↗
• MalfunctionMar 17, 2026Failure to Deliver

  IT WAS REPORTED THE PATIENT'S OMNIPOD DASH CONTROLLER/PERSONAL DIABETES MANAGER (PDM) DID NOT DELIVER A BOLUS. NO MESSAGES APPEARED ON THE PDM DISPLAY. THE PATIENT REMOVED THE POD. NO HARM TO THE PATIENT WAS REPORTED AND NO MEDICAL ASSISTANCE WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615864 ↗
• MalfunctionMar 13, 2026Failure to Deliver

  IT WAS REPORTED BY THE PATIENT THAT THEIR DASH SYSTEM WAS NOT DELIVERING BOLUSES THROUGHOUT THE NIGHT AND INTO THE NEXT DAY WITH NO ERROR MESSAGE PRODUCED. NO MEDICAL ASSISTANCE WAS REQUIRED AND THEY REPORTED THEIR BLOOD GLUCOSE VALUES REMAINED STABLE. THE PATIENT APPLIED A NEW POD AND REPORTED NO FURTHER ISSUES, CONFIRMING THAT BOLUSES WERE BEING DELIVERED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24589096 ↗