Latest Updates
Insulet announced March 12, 2026 that specific Omnipod 5 Pod lots have small tears in internal tubing delivering insulin, causing insulin to leak inside pods instead of being infused into bodies as intended. [1] Eighteen serious adverse events including hospitalizations and diabetic ketoacidosis occurred, with no deaths reported. [1]
Internal Tubing Tear Defect
Manufacturing issues caused small tears in internal tubing delivering insulin from pods to users. Tears allow insulin to leak into pod interiors rather than flowing through tubing into subcutaneous tissue.
Users receive insufficient insulin doses when leaks occur. Under-delivery causes blood glucose levels to rise dangerously as bodies lack insulin regulating blood sugar.
Diabetic Ketoacidosis Risk
Prolonged high blood glucose from insulin under-delivery leads to diabetic ketoacidosis (DKA), a life-threatening condition requiring emergency treatment. DKA occurs when bodies break down fat for energy without sufficient insulin, producing dangerous acid levels.
Eighteen serious adverse events included DKA cases requiring hospitalization. DKA symptoms include extreme thirst, frequent urination, nausea, vomiting, abdominal pain, confusion, and fruity-scented breath. Untreated DKA causes coma and death.
Affected Product Lots
The defect affects specific lots representing approximately 1.5% of annual Omnipod 5 pod production globally. Customers must visit omnipod.com/check-pods to verify if their lot numbers are affected and request free replacement pods.
Users with affected pods in use should discontinue immediately and replace with unaffected lots. All other Omnipod 5 pods and Omnipod products remain safe.
Manufacturing Process Failures
Insulet’s manufacturing processes failed to prevent or detect tubing tears before pods reached consumers. Quality control systems should identify structural defects through visual inspection and pressure testing.
The company implemented manufacturing process updates and enhanced quality controls after discovering the issue. The delayed detection allowed defective pods to reach users causing serious medical emergencies.
Product Liability Claims
Insulin pumps with tubing defects causing under-delivery are defectively manufactured. Pods deviating from design specifications through production errors creating DKA risks trigger strict liability.
Design Defect Claims
If tubing design makes tears likely during manufacturing or use, design defect claims apply. Tubing must withstand manufacturing processes and normal use without tearing or developing leaks.
Failure to Warn
Insulet sold pods with tubing defects without warnings about insulin leak risks and DKA dangers. Manufacturers discovering defects causing life-threatening conditions must warn users immediately or recall products.
Negligent Quality Control
Insulet breached duties to inspect pods for tubing integrity before distribution. Reasonable quality control requires detecting structural defects preventing proper insulin delivery. Distributing 1.5% of annual production with identical defects demonstrates inadequate testing.
Personal Injury Claims
Diabetics experiencing DKA from defective pods may recover emergency room costs, hospitalization expenses, intensive care treatment, lost wages during recovery, and pain and suffering. DKA causes severe dehydration, electrolyte imbalances, and organ stress requiring intensive monitoring.
Complications from Delayed Treatment
Users not recognizing DKA symptoms promptly face complications including kidney damage, brain swelling, fluid accumulation in lungs, cardiac arrest, coma, and death. Delayed DKA treatment causes permanent organ damage warranting substantial compensation.
Hypoglycemia from Overcompensation
Users discovering high blood glucose may administer correction doses not realizing pods are malfunctioning. When defective pods are replaced with functioning ones, accumulated insulin causes dangerous hypoglycemia requiring emergency treatment.
Medical Monitoring Costs
Diabetics experiencing DKA require ongoing monitoring for kidney function, cardiovascular health, and neurological effects. DKA episodes increase long-term complication risks including retinopathy, neuropathy, and cardiovascular disease.
Breach of Warranty
Insulet breached implied warranties of merchantability by selling pods unfit for their purpose of reliable insulin delivery. Pods with torn tubing fail to meet basic safety and functionality standards users expect.
Punitive Damages
If evidence shows Insulet knew about tubing defects before the correction but delayed action, punitive damages may apply. Continuing to distribute defective medical devices after discovering serious adverse events demonstrates reckless disregard warranting punitive awards.
Contact an Attorney
If you experienced DKA, hospitalization, or complications from defective Omnipod 5 pods, contact a medical device attorney. Preserve affected pods with lot numbers, replacement pod documentation, medical records documenting DKA diagnosis and treatment, and blood glucose monitoring data.
References
1. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/insulet-initiates-voluntary-medical-device-correction-certain-omnipodr-5-pods-us