Omnipod 5 Pod POD-OMNI-I1-6220Recalls & reported problems
Insulet Corporation · Omnipod 5 Pod · Class 2
All models of Omnipod 5 (8) · Omnipod 5 Pod (3)
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 Insulet Omnipod 5 insulin pod has 1,227 adverse event reports, with no deaths and 183 injuries. Most reports describe high blood sugar in patients, and others describe the cannula failing to insert or retracting, adhesive failing to stick, or leaks. There is 1 open recall, started in May 2026, about damage to the soft cannula during manufacturing that can cause insulin to leak around the pod instead of being delivered. Reports in the last 12 months (959) are far more than in the 12 months before (268).
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
- 1,191
- Deaths reported
- 0
- Injuries reported
- 178
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,191 adverse event reports that list this exact device (DI 10385083000411), received between Feb 21, 2025 and Sep 30, 2026 — classified as 178 injuries, 1,013 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (359 reports).
1 FDA recall record name this device's 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, 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-2603-2026 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Unintended Movement359
- Loss of or Failure to Bond322
- Material Twisted/Bent223
- Failure to Fire171
- Insufficient Device Problem Information168
- Fluid/Blood Leak128
- Difficult to Insert127
- Activation, Positioning or Separation Problem95
Patient problems
- Hyperglycemia793
- No Clinical Signs, Symptoms or Conditions336
- Elevated Ketones/ Diabetic Ketoacidosis67
- Erythema50
- Vomiting46
- Hemorrhage/Blood Loss/Bleeding34
- Pain34
- Nausea29
Recent adverse event reports
The 25 most recent of 1,191 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954795 ↗MalfunctionSep 30, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953704 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Difficult to Insert
It was reported that the patient's blood glucose level rose greater than 250 mg/dL while wearing the Pod between 24 and 36 hours. The patient reported being unsure if the cannula was properly seated in the infusion site (Abdomen) and leaking was observed.
Patient problems: Hyperglycemia
MAUDE report 50950720 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Difficult to Insert; Material Twisted/Bent
It was reported that the patient's blood glucose level rose to 400 mg/dL while wearing the Pod between 4 and 24 hours. The patient reported being unsure if the cannula was properly seated in the infusion site (Abdomen) The cannula was also observed to be bent and leaking.
Patient problems: Hyperglycemia
MAUDE report 50950567 ↗MalfunctionSep 30, 2026Material Twisted/Bent; Insufficient Device Problem Information
It was reported the patient's blood glucose level rose to 290 mg/dL while wearing the Pod between 1 and 4 hours. When the Pod was removed from the infusion site (Arm), the Pod's cannula was found bent.
Patient problems: Hyperglycemia
MAUDE report 50947424 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Material Twisted/Bent
It was reported the patient's blood glucose level rose to 260 mg/dL while wearing the Pod between 24 and 36 hours. When the Pod was removed from the infusion site (Abdomen), the Pod's cannula was found bent and leaking was observed.
Patient problems: Erythema; Hyperglycemia; Swelling/ Edema
MAUDE report 50946935 ↗MalfunctionSep 30, 2026Difficult or Delayed Activation
It was reported that the needle deployed late when the Pod was activated; this indicates a needle mechanism failure. No impact to the patient's glucose level was reported. The Pod was not worn. There is no report of medical intervention.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945633 ↗MalfunctionSep 29, 2026Fluid/Blood Leak; Unintended Movement
It was reported the patient's blood glucose level rose to 438 mg/dL while wearing the Pod between 4 and 24 hours. The adhesive completely separated from the (Abdomen) causing the cannula to dislodge and leaking was observed.
Patient problems: Hyperglycemia
MAUDE report 50937478 ↗MalfunctionSep 29, 2026Obstruction of Flow
It was reported the patient's blood glucose level rose to 409 mg/dL while wearing the Pod longer than 48 hours. When removed from the infusion site (Abdomen), the Pod's cannula was found blocked.
Patient problems: Erythema; Hemorrhage/Blood Loss/Bleeding; Hyperglycemia; Swelling/ Edema
MAUDE report 50937323 ↗MalfunctionSep 29, 2026Unintended Movement; Insufficient Device Problem Information
It was reported the patient's blood glucose level rose to 409 mg/dL while wearing the Pod. The adhesive completely separated from the (Abdomen) causing the cannula to dislodge.
Patient problems: Erythema; Hemorrhage/Blood Loss/Bleeding; Hyperglycemia; Swelling/ Edema
MAUDE report 50937315 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Fluid/Blood Leak; Material Twisted/Bent
It was reported the patient's blood glucose level rose to 400 mg/dL while wearing the Pod between 4 and 24 hours. The Pod was leaking, causing the adhesive to peel up, and when the Pod was removed from the infusion site (Leg), the Pod's cannula was found bent. As treatment, a new Pod was applied.
Patient problems: Hyperglycemia
MAUDE report 50936686 ↗MalfunctionSep 29, 2026Fluid/Blood Leak; Difficult to Insert
It was reported that the patient's blood glucose level rose to 384 mg/dL while wearing the Pod between 4 and 24 hours. The patient reported being unsure if the cannula was properly seated in the infusion site (arm) and leaking was observed.
Patient problems: Hyperglycemia
MAUDE report 50936446 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Difficult to Insert; Material Twisted/Bent
It was reported by the legal guardian (LG) that the patient's blood glucose level rose to 310-320 mg/dL while wearing the Pod between 36 and 48 hours despite boluses. The LG reported smelling insulin and the adhesive was pulling off. The LG reported being unsure if the cannula was properly seated in the infusion site and when removed, the Pod's cannula was found bent. As treatment, the LG planned to apply a new Pod.
Patient problems: Hyperglycemia
MAUDE report 50935360 ↗MalfunctionSep 29, 2026Material Twisted/Bent
It was reported the patient's blood glucose level rose to 350 mg/dL while wearing the Pod between 36 and 48 hours. When the Pod was removed from the infusion site (Arm), the Pod's cannula was found bent.
Patient problems: Hyperglycemia
MAUDE report 50934902 ↗MalfunctionSep 29, 2026Fluid/Blood Leak; Difficult to Insert
It was reported that the patient's blood glucose level rose to over 400 mg/dL while wearing the Pod between 4 and 24 hours. The patient reported that the Pod was leaking being unsure if the cannula was properly seated in the infusion site (Arm). As treatment, a new Pod was applied and a bolus was administered.
Patient problems: Hyperglycemia
MAUDE report 50934429 ↗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 4 and 24 hours. The Pod reportedly detached from the arm, causing the cannula to dislodge. Details regarding treatment were not provided.
Patient problems: Hyperglycemia
MAUDE report 50934025 ↗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 4 and 24 hours. The Pod reportedly detached from the abdomen, causing the cannula to dislodge. Details regarding treatment were not provided.
Patient problems: Hyperglycemia
MAUDE report 50933849 ↗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 4 and 24 hours. The Pod reportedly detached from the arm, causing the cannula to dislodge. Details regarding treatment were not provided.
Patient problems: Hyperglycemia
MAUDE report 50933839 ↗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 24 and 36 hours. The Pod reportedly detached from the arm, causing the cannula to dislodge. Details regarding treatment were not provided.
Patient problems: Hyperglycemia
MAUDE report 50933832 ↗MalfunctionSep 29, 2026Failure to Fire
It was reported by the patient that the needle did not move forward when the Pod was activated; this indicates a needle mechanism failure. The Pod was worn for greater than 48 hours. No impact to the patient's glucose level was reported. As treatment, a new Pod was placed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933728 ↗MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933713 ↗MalfunctionSep 29, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933691 ↗MalfunctionSep 29, 2026Fluid/Blood Leak; Difficult to Insert
It was reported that the patient's blood glucose level rose to over 400 mg/dL while wearing the Pod between 4 and 24 hours. The patient reported the Pod was leaking and being unsure if the cannula was properly seated in the infusion site (Arm). As treatment, a new Pod was applied and a bolus was administered.
Patient problems: Hyperglycemia
MAUDE report 50932564 ↗MalfunctionSep 29, 2026Fluid/Blood Leak; Retraction Problem
It was reported by the patient the cannula retracted, indicating a needle mechanism failure. No impact to the patient's blood glucose level was reported. The Pod was worn for less than one hour. When the Pod was removed from the infusion site, it was observed there was leaking. There was no report of medical intervention.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931737 ↗MalfunctionSep 29, 2026Material Twisted/Bent
It was reported the patient's blood glucose level rose to 397 mg/dL while wearing the Pod between 36 and 48 hours. Despite attempting to correct with a manual insulin injection using a pen, the patient's blood glucose levels remained elevated. When the Pod was removed from the infusion site (Arm), the Pod's cannula was found bent. As a treatment, a new Pod was applied.
Patient problems: Hyperglycemia
MAUDE report 50931695 ↗
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- t:slim X2 Insulin Pump with Control-IQ 1009643Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall7 deaths51,110 reports
- t:slim X2 Insulin Pump with Control-IQ Technology 1013198Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall8 deaths47,637 reports
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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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