Omnipod 5 Pod POD-BLE-H1-520Recalls & reported problems
Insulet Corporation · Omnipod 5 Pod · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is an Insulet Omnipod 5 pod. Its reports mostly describe needles or cannulas that fail to insert, pods falling off or leaking, and pods that fail to connect. There are 71,566 reports, including 80 deaths and 9,144 injuries. One recall, started in May 2026, is open: a cannula damaged during manufacturing can let insulin leak around the pod. Reports dropped to 6,931 in the last 12 months, from 15,650 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
- 71,459
- Deaths reported
- 75
- Injuries reported
- 9,237
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 71,459 adverse event reports that list this exact device (DI 10385083000114), received between Mar 8, 2022 and Sep 30, 2026 — classified as 75 deaths, 9,237 injuries, 62,147 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (32,826 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. 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 ↗
Most reported problems
Device problems
- Unintended Movement32,826
- Loss of or Failure to Bond29,085
- Material Twisted/Bent12,584
- Insufficient Device Problem Information8,278
- Failure to Fire7,837
- Fluid/Blood Leak6,228
- Difficult to Insert4,944
- Activation, Positioning or Separation Problem3,266
Patient problems
- Hyperglycemia53,867
- No Clinical Signs, Symptoms or Conditions13,392
- Elevated Ketones/ Diabetic Ketoacidosis2,815
- Vomiting1,779
- Hypoglycemia1,539
- Erythema1,524
- Pain1,488
- Skin Inflammation/ Irritation1,356
Recent adverse event reports
The 25 most recent of 71,459 reports, in the reporter's own words as published by the FDA.
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: Erythema; Pain; Skin Infection; Swelling/ Edema
MAUDE report 50955100 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50954707 ↗InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954680 ↗MalfunctionSep 30, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953650 ↗InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: Scar Tissue
MAUDE report 50953647 ↗InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: Scar Tissue
MAUDE report 50953562 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50953273 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50952468 ↗InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: Scar Tissue; Skin Inflammation/ Irritation
MAUDE report 50952166 ↗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 37 and 48 hours. The adhesive completely separated from the (Arm) causing the cannula to dislodge. As treatment, A new pod was inserted
Patient problems: Hyperglycemia
MAUDE report 50950960 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
It was reported that the patient's blood glucose level rose to 380 mg/dL while wearing the Pod between 5 and 24 hours. The adhesive completely separated from the (Abdomen) causing the cannula to dislodge. As treatment, A new pod was inserted
Patient problems: Hyperglycemia
MAUDE report 50950892 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
It was reported that the patient's blood glucose level rose to 343 mg/dL while wearing the Pod between 5 and 24 hours. The adhesive completely separated from the (Arm) causing the cannula to dislodge. As treatment, A new pod was inserted
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950526 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
It was reported that the patient's blood glucose level rose to (21 mmol/L) (378 mg/dL) while wearing the Pod between 1 and 4 hours. The adhesive completely separated from the (Arm) causing the cannula to dislodge. As treatment, A new pod was inserted
Patient problems: Hyperglycemia
MAUDE report 50950497 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
Patient problems: Hyperglycemia
MAUDE report 50950476 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Fluid/Blood Leak; Unintended Movement
It was reported that the patient's blood glucose level rose to greater than 250 mg/dL, while wearing the Pod longer than 48 hours. The Pod reportedly detached from the arm, causing the cannula to dislodge. Additionally, leaking at the Pod site was reported. Details regarding treatment were not provided.
Patient problems: Hyperglycemia
MAUDE report 50950472 ↗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 1 and 4 hours. The adhesive completely separated from the (Arm) causing the cannula to dislodge. As treatment, A new pod was inserted
Patient problems: Hyperglycemia
MAUDE report 50950436 ↗MalfunctionSep 30, 2026Activation, Positioning or Separation Problem
It was reported by the patient that the needle never deployed the cannula into the skin. They also reported that the adhesive caused their skin to break out. The patient was unable to be reached to obtain further information.
Patient problems: Rash
MAUDE report 50950420 ↗MalfunctionSep 30, 2026Activation, Positioning or Separation Problem
It was reported that the patient's blood glucose level reached 233 mg/dL while wearing the Pod for less than an hour. It was reported that the pink slide did not move forward, this indicates a failure of the needle mechanism. The patient decided to continue to wear the Pod as they believe the cannula still inserted.
Patient problems: Hyperglycemia
MAUDE report 50949966 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Unintended Movement
It was reported the patient's blood glucose level rose above 400 mg/dL while wearing the Pod between 5 and 24 hours. The Pod reportedly was coming loose from the infusion site (unspecified), causing the cannula to dislodge. As treatment, a new Pod was applied.
Patient problems: Hyperglycemia
MAUDE report 50949620 ↗MalfunctionSep 30, 2026Fluid/Blood Leak; Material Twisted/Bent
It was reported the patient's blood glucose level rose to 366 mg/dL while wearing the Pod for 24 hours. When the Pod was removed from the infusion site (arm), the Pod's cannula was found bent and leaking insulin. As treatment, they applied and activated a new Pod at a different site, it worked without any problems.
Patient problems: Hyperglycemia
MAUDE report 50949333 ↗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 Pod reportedly detached from the leg, causing the cannula to dislodge. As treatment, a new pod was placed.
Patient problems: Hyperglycemia
MAUDE report 50949093 ↗MalfunctionSep 30, 2026Obstruction of Flow
It was reported the patient's blood glucose level rose above 250 mg/dL while wearing the Pod between 37 and 48 hours. When removed from the infusion site (leg), the Pod's cannula was found blocked. As treatment, a new Pod was applied.
Patient problems: Hyperglycemia
MAUDE report 50949000 ↗MalfunctionSep 30, 2026Material Twisted/Bent
It was reported the patient's blood glucose level rose to 18mmol/L (324 mg/dL) while wearing the Pod between 25 and 36 hours. When the Pod was removed from the infusion site (arm), the Pod's cannula was found bent. As treatment, a new pod applied.
Patient problems: Hyperglycemia
MAUDE report 50948725 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.