Omnipod DASHRecalls & reported problems across all models
Insulet Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Omnipod DASH model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 57,338
- Deaths reported
- 40
- Injuries reported
- 5,256
- Recalls
- 2
We found 2 models of Omnipod DASH by Insulet Corporation in the FDA's device registry (GUDID). Together they are named in 57,338 adverse event reports in the FDA's MAUDE database, received between Nov 26, 2018 and Sep 30, 2026 — classified as 40 deaths, 5,256 injuries, 52,041 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (19,496 reports).
2 FDA recall records name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Omnipod DASH recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 20, 2026Open, Classified
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an external leak. If insulin is not delivered properly, users may experience high blood glucose levels due to under-delivery of insulin. In the most severe cases, prolonged and persistent high blood glucose levels can lead to diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death.
Z-2604-2026 · Root cause: Process design · Recall details · FDA record ↗
- Oct 17, 2022Terminated
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 Omnipod DASH problems
Device problems
- Unintended Movement19,496
- Loss of or Failure to Bond15,890
- Material Twisted/Bent13,732
- Failure to Fire6,829
- Insufficient Device Problem Information5,505
- Fluid/Blood Leak4,235
- Difficult to Insert4,051
- Premature Activation3,409
Patient problems
- Hyperglycemia40,868
- No Clinical Signs, Symptoms or Conditions12,559
- No Information1,398
- Skin Inflammation/ Irritation1,313
- Elevated Ketones/ Diabetic Ketoacidosis1,264
- Pain1,194
- Vomiting931
- Skin Infection777
Omnipod DASH models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Omnipod DASH Pod POD-BLE-11-520Pump, Infusion, Insulin1 recall30 deaths56,209 reports
- Omnipod DASH PDM PDM-USA1-D001-MG-USA1System, Test, Blood Glucose, Over The Counter1 recall10 deaths1,129 reports
Recent Omnipod DASH adverse event reports
The 15 most recent reports across all models, 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 30, 2026Loss of or Failure to Bond; Fluid/Blood Leak; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50954563 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Fluid/Blood Leak; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50954537 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50952795 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50952697 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50952633 ↗MalfunctionSep 30, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952146 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Material Twisted/Bent; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50951294 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50951249 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
It was reported that the patient's blood glucose level rose to greater than 250 mg/dL while wearing the Pod between 5 and 24 hours. The adhesive completely separated from the (Leg) causing the cannula to dislodge. As treatment, A new pod was inserted.
Patient problems: Hyperglycemia
MAUDE report 50949735 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Unintended Movement
It was reported by the patient's mother that the patient's blood glucose level rose to 280 mg/dL while wearing the Pod between 5 and 24 hours. The Pod cannula was reportedly dislodged from the infusion site (abdomen), causing insulin to leak during wear. As treatment, a new Pod was applied.
Patient problems: Hyperglycemia
MAUDE report 50949228 ↗MalfunctionSep 30, 2026Premature Activation
It was reported the needle mechanism had fully deployed before the Pod was able to be used. No impact to the patient's glucose level was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946902 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Unintended Movement
It was reported the patient's blood glucose level rose to greater than 250 mg/dL while wearing the Pod between 24 and 36 hours. The adhesive completely separated from the infusion site (leg), causing the cannula to dislodge. Treatment details not provided.
Patient problems: Hyperglycemia
MAUDE report 50937676 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Unintended Movement
It was reported the patient's blood glucose level rose to 300 mg/dL while wearing the Pod between 25 and 36 hours. The Pod reportedly fell off the infusion site (leg), causing the cannula to dislodge. As treatment, a new Pod was applied.
Patient problems: Hyperglycemia
MAUDE report 50937466 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50937207 ↗
Other Insulet Corporation products
All Insulet Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered, combining the brand names used for this product line.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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