Omnipod 5 PodRecalls & reported problems across all models
Insulet Corporation · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one Omnipod 5 Pod model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 133,848
- Deaths reported
- 86
- Injuries reported
- 13,672
- Recalls
- 2
We found 3 models of Omnipod 5 Pod by Insulet Corporation in the FDA's device registry (GUDID). Together they are named in 133,848 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2022 and Sep 30, 2026 — classified as 86 deaths, 13,672 injuries, 120,087 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (64,009 reports).
2 FDA recall records name at least one of these models by its device 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. 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 5 Pod 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-2603-2026 · Root cause: Process design · names 3 of these models · Recall details · 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 · Recall details · FDA record ↗
Most reported Omnipod 5 Pod problems
Device problems
- Unintended Movement64,009
- Loss of or Failure to Bond57,949
- Material Twisted/Bent23,939
- Insufficient Device Problem Information13,727
- Fluid/Blood Leak13,647
- Failure to Fire13,618
- Difficult to Insert10,223
- Activation, Positioning or Separation Problem6,043
Patient problems
- Hyperglycemia104,265
- No Clinical Signs, Symptoms or Conditions23,829
- Elevated Ketones/ Diabetic Ketoacidosis4,277
- Erythema3,393
- Vomiting3,068
- Pain2,812
- Hemorrhage/Blood Loss/Bleeding2,666
- Swelling/ Edema2,230
Omnipod 5 Pod models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Omnipod 5 Pod POD-BLE-H1-520Alternate Controller Enabled Insulin Infusion Pump1 recall75 deaths71,459 reports
- Omnipod 5 Pod POD-OMNI-I1-6720Alternate Controller Enabled Insulin Infusion Pump2 recalls11 deaths61,198 reports
- Omnipod 5 Pod POD-OMNI-I1-6220Alternate Controller Enabled Insulin Infusion Pump1 recall1,191 reports
Recent Omnipod 5 Pod adverse event reports
The 15 most recent reports across all models, 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: Skin Infection
MAUDE report 50955161 ↗InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: Skin Infection
MAUDE report 50955159 ↗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 ↗InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: Erythema; Pain; Skin Infection; Swelling/ Edema
MAUDE report 50955100 ↗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, 2026Retraction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954795 ↗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 ↗
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.
- 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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