Omnipod 5 Pod POD-OMNI-I1-6720Recalls & reported problems
Insulet Corporation · Omnipod 5 Pod · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is an Omnipod 5 pod. Its reports mostly describe pods coming loose or leaking and cannulas that do not deploy. There are 63,471 reports, including 9 deaths and 4,206 injuries. Two recalls are open: cannulas damaged during manufacturing can leak insulin around the pod, and certain pods have cannula tears from a manufacturing problem. Reports rose to 38,902 in the last 12 months, from 23,754 before.
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
- 61,198
- Deaths reported
- 11
- Injuries reported
- 4,257
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 61,198 adverse event reports that list this exact device (DI 10385083000527), received between Mar 7, 2024 and Sep 30, 2026 — classified as 11 deaths, 4,257 injuries, 56,927 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (30,824 reports).
2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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-2603-2026 · Root cause: Process design · FDA record ↗
- Mar 12, 2026Open, Classified
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear.
Z-1797-2026 · Root cause: Process design · FDA record ↗
Most reported problems
Device problems
- Unintended Movement30,824
- Loss of or Failure to Bond28,542
- Material Twisted/Bent11,132
- Fluid/Blood Leak7,291
- Failure to Fire5,610
- Insufficient Device Problem Information5,281
- Difficult to Insert5,152
- Activation, Positioning or Separation Problem2,682
Patient problems
- Hyperglycemia49,605
- No Clinical Signs, Symptoms or Conditions10,101
- Erythema1,819
- Hemorrhage/Blood Loss/Bleeding1,591
- Elevated Ketones/ Diabetic Ketoacidosis1,395
- Pain1,290
- Vomiting1,243
- Swelling/ Edema1,079
Recent adverse event reports
The 25 most recent of 61,198 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Obstruction of Flow
Patient problems: Hyperglycemia
MAUDE report 50955185 ↗InjurySep 30, 2026Loss of or Failure to Bond; Insufficient Device Problem Information
Patient problems: Eczema
MAUDE report 50955170 ↗InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: Extreme Exhaustion; Headache; Hyperglycemia; Malaise
MAUDE report 50955140 ↗InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Nausea; Polydipsia; Urinary Frequency / Polyuria; Vomiting
MAUDE report 50955137 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50955123 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Fluid/Blood Leak; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50954897 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50954863 ↗MalfunctionSep 30, 2026Premature Activation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954827 ↗MalfunctionSep 30, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954819 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50954736 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50954726 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50954674 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50954658 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50954624 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50954583 ↗InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: Erythema; Pain; Skin Inflammation/ Irritation; Unspecified Infection
MAUDE report 50954578 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50954567 ↗MalfunctionSep 30, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50954564 ↗MalfunctionSep 30, 2026Failure to Fire
Patient problems: Hyperglycemia
MAUDE report 50954450 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50954266 ↗MalfunctionSep 30, 2026Difficult to Insert
Patient problems: Hyperglycemia
MAUDE report 50954150 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Fluid/Blood Leak; Material Twisted/Bent; Unintended Movement; Insufficient Device Problem Information
Patient problems: Hemorrhage/Blood Loss/Bleeding; Hyperglycemia
MAUDE report 50953987 ↗MalfunctionSep 30, 2026Activation, Positioning or Separation Problem; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50953879 ↗MalfunctionSep 30, 2026Activation, Positioning or Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953786 ↗InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: Hypoglycemia; Loss of consciousness
MAUDE report 50953682 ↗
Other Alternate Controller Enabled Insulin Infusion Pump devices
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- t:slim X2 Insulin Pump with Control-IQ 1009637Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall4 deaths83,884 reports
- Omnipod 5 Pod POD-BLE-H1-520Insulet Corporation · Alternate Controller Enabled Insulin Infusion Pump1 recall75 deaths71,459 reports
- 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
- t:slim X2 Insulin Pump with Control-IQ 1006404Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall18 deaths43,718 reports
- t:slim X2 Insulin Pump with Control-IQ 1005011Tandem Diabetes Care, Inc. · Alternate Controller Enabled Insulin Infusion Pump1 recall3 deaths35,600 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.