Omnipod DASH Pod POD-BLE-11-520Recalls & reported problems
Insulet Corporation · DASH Pod · Class 2
All models of Omnipod DASH (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is an Omnipod DASH pod. Its reports mostly describe pods falling off or adhesive separating so the cannula dislodges, needle failures and rising blood glucose. There are 56,348 reports, including 30 deaths and 4,896 injuries. One recall, started in May 2026, is open: cannulas damaged during manufacturing can let insulin leak around the pod instead of reaching the user.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 56,209
- Deaths reported
- 30
- Injuries reported
- 4,913
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 56,209 adverse event reports that list this exact device (DI 10385082000023), received between Nov 26, 2018 and Sep 30, 2026 — classified as 30 deaths, 4,913 injuries, 51,265 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (19,491 reports).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K180045); they may or may not involve this specific model.
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.
Reports received per month
Recalls naming this device
- May 20, 2026Class IOpen, 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 ↗
Most reported problems
Device problems
- Unintended Movement19,491
- Loss of or Failure to Bond15,888
- Material Twisted/Bent13,730
- Failure to Fire6,829
- Insufficient Device Problem Information5,316
- Fluid/Blood Leak4,224
- Difficult to Insert4,049
- Premature Activation3,408
Patient problems
- Hyperglycemia40,609
- No Clinical Signs, Symptoms or Conditions11,875
- No Information1,373
- Skin Inflammation/ Irritation1,313
- Pain1,183
- Elevated Ketones/ Diabetic Ketoacidosis1,153
- Vomiting879
- Skin Infection776
Recent adverse event reports
The 25 most recent of 56,209 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Unintended Movement
It was reported the patient's blood glucose level rose to 260 mg/dL while wearing the Pod between 5 and 24 hours. The Pod reportedly fell off the infusion site (back), causing the cannula to dislodge. As treatment, he corrected with pen 12 units and a new Pod was applied.
Patient problems: Hyperglycemia
MAUDE report 50936685 ↗MalfunctionSep 29, 2026Fluid/Blood Leak; Unintended Movement
It was reported by the legal guardian that the patient's blood glucose level rose to 330 mg/dL while wearing the Pod between 5 and 24 hours. When removed from the infusion site (abdomen), the Pod's cannula was found to be dislodged and the Pod was leaking insulin. The patient also experienced some bleeding. As treatment, a new Pod was applied.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Hyperglycemia
MAUDE report 50936672 ↗MalfunctionSep 29, 2026Difficult to Insert
It was reported by the mothere of the patient that the patient's blood glucose level rose to 300 mg/dL while wearing the Pod between 1 and 4 hours. The patient reported being unsure if the cannula was properly seated in the infusion site (leg). It was reported irritation, swelling, pain and redness on the skin. As treatment, a new Pod was applied.
Patient problems: Erythema; Hyperglycemia; Pain
MAUDE report 50935727 ↗MalfunctionSep 29, 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 less than an hour. The Pod reportedly detached from the leg, causing the cannula to dislodge. As treatment, a new pod was placed.
Patient problems: Hyperglycemia
MAUDE report 50935638 ↗MalfunctionSep 29, 2026Difficult to Insert
It was reported that the patient's blood glucose level rose to 348 mg/dL while wearing the Pod between 4 and 24 hours. The patient reported that the cannula scratched their skin causing bleeding instead of properly seating in the infusion site (Arm). As treatment, a new Pod was applied
Patient problems: Hemorrhage/Blood Loss/Bleeding; Hyperglycemia; Skin Inflammation/ Irritation
MAUDE report 50935456 ↗MalfunctionSep 29, 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 Pod reportedly detached from the abdomen, causing the cannula to dislodge. As treatment, a new pod was placed.
Patient problems: Hyperglycemia
MAUDE report 50934176 ↗MalfunctionSep 29, 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 1 and 4 hours. The Pod reportedly detached from the abdomen, causing the cannula to dislodge. As treatment, a new pod was placed.
Patient problems: Hyperglycemia
MAUDE report 50934171 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Unintended Movement
It was reported the patient's blood glucose level rose greater than 250 mg/dL while wearing the Pod between 25 and 36 hours. The adhesive completely separated from the infusion site (Arm) causing the cannula to dislodge. The patient was able to successfully remove a Pod and apply a new Pod.
Patient problems: Hyperglycemia
MAUDE report 50927549 ↗MalfunctionSep 29, 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. No medical assistance was required.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927416 ↗MalfunctionSep 29, 2026Material Twisted/Bent; Insufficient Device Problem Information
It was reported by the legal guardian that the patient's blood glucose level rose to 400 mg/dL while wearing the Pod between 5 and 24 hours. When the Pod was removed from the infusion site (leg), the Pod's cannula was found bent and the skin was red. As treatment, a new Pod was applied.
Patient problems: Erythema; Hyperglycemia
MAUDE report 50927197 ↗MalfunctionSep 28, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926119 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K180045. One submission often covers many models, so check the product and lot details in each record.
- Z-0347-2020 · Dec 18, 2018 · TerminatedOmnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Other Pump, Infusion, Insulin devices
- Omnipod ZXP420Insulet Corporation · Pump, Infusion, Insulin1 recall17 deaths37,832 reports
- Omnipod ZXP420Insulet Corporation · Pump, Infusion, Insulin70 deaths20,092 reports
- t:slim X2 Insulin Pump 1000103Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin1 recall1 death7,327 reports
- t:slim Insulin Pump, Reconditioned Replacement 007262Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin2 deaths5,253 reports
- t:flex Insulin Pump, Replacement, Refurbished 007473Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin2 deaths2,373 reports
- t:slim Insulin Pump 007435Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin7 deaths2,104 reports
- Accu-Chek Combo 05027250001Roche Diabetes Care GmbH · Pump, Infusion, Insulin1,830 reports
- t:slim X2 Insulin Pump 1000369Tandem Diabetes Care, Inc. · Pump, Infusion, Insulin1 recall1,640 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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